Alopecia – Hair Regrowth

Lasers Med Sci. 2017 Aug 16. doi: 10.1007/s10103-017-2306-7. [Epub ahead of print]

Efficacy of fractional lasers in treating alopecia: a literature review.

Perper M1, Aldahan AS2, Fayne RA2, Emerson CP2, Nouri K2.

Author information

1
Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, 1475 NW 12th Ave. Suite 2175, Miami, FL, 33136, USA. m.perper@umiami.edu.
2
Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, 1475 NW 12th Ave. Suite 2175, Miami, FL, 33136, USA.

Abstract

Hair loss stemming from different types of alopecia, such as androgenic alopecia and alopecia areata, negatively affects over half the population and, in many circumstances, causes serious psychosocial distress. Current treatment options for alopecia, such as minoxidil, anthralin, and intralesional corticosteroids, vary efficacy and side effect profiles. It is known that low-level laser/light therapies (LLLT), or photobiomodulations, such as the US FDA-cleared HairMax Lasercomb®, He-Ne laser, and excimer laser, are relatively affordable, user-friendly, safe, and effective forms of treatment for hair loss. While less is known about the effectiveness of fractional lasers for combating hair loss, research suggests that by creating microscopic thermal injury zones, fractional lasers may cause an increase in hair growth from a wound healing process, making them potential therapeutic options for alopecia. A literature review was performed to evaluate the effectiveness of fractional lasers on hair regrowth. The specific fractional laser therapies include the 1550-nm nonablative fractional erbium-glass laser, the ablative fractional 2940-nm erbium:YAG laser, and the ablative fractional CO2 fractional laser. Additional randomized controlled trials are necessary to further evaluate the effectiveness of the lasers, as well as to establish appropriate parameters and treatment intervals.

Dermatol Surg. 2016 Sep 9. [Epub ahead of print]

A Critical Assessment of the Evidence for Low-Level Laser Therapy in the Treatment of Hair Loss.

Gupta AK1, Foley KA.

Author information

  • 1*Department of Medicine, University of Toronto School of Medicine, Toronto, Ontario, Canada; †Mediprobe Research Inc., London, Ontario, Canada.

Abstract

BACKGROUND:

Low-level laser therapy (LLLT) is currently in use to stimulate hair growth and is quickly gaining in popularity due to the ease of use and absence of side effects. In 2015 alone, the number of LLLT devices with the Food and Drug Administration clearance has doubled.

OBJECTIVE:

To consolidate evidence and establish which data are still required for the widespread acceptance of LLLT for hair loss therapy.

METHODS AND MATERIALS:

A thorough search of the PubMed database was conducted to obtain studies investigating LLLT for androgenetic alopecia in men and women.

RESULTS:

Nine trials were identified for comb and helmet/cap devices, five of which were randomized controlled trials. Data comparison across LLLT trials and with traditional hair loss therapy (minoxidil, finasteride) was not straight forward because there was a lack of visual evidence, sample sizes were low, and there were large variations in study duration and efficacy measurements.

CONCLUSION:

There are a number of unanswered questions about the optimum treatment regimen, including maintenance treatment and the long-term consequences of LLLT use. Moving forward, protocols should be standardized across trials. Moreover, it is recommended that future trials include visual evidence and trial duration be expanded to 12 months.

Lasers Med Sci. 2015 Dec 21. [Epub ahead of print]

Low level laser therapy and hair regrowth: an evidence-based review.

Zarei M1, Wikramanayake TC1, Falto-Aizpurua L1, Schachner LA1, Jimenez JJ2.
Author information
1Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Ave., RMSB 2023, Miami, FL, 33136, USA.
2Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Ave., RMSB 2023, Miami, FL, 33136, USA. jjimenez@med.miami.edu.
Abstract
Despite the current treatment options for different types of alopecia, there is a need for more effective management options. Recently, low-level laser therapy (LLLT) was evaluated for stimulating hair growth. Here, we reviewed the current evidence on the LLLT effects with an evidence-based approach, focusing more on randomized controlled studies by critically evaluating them. In order to investigate whether in individuals presenting with hair loss (male pattern hair loss (MPHL), female pattern hair loss (FPHL), alopecia areata (AA), and chemotherapy-induced alopecia (CIA)) LLLT is effective for hair regrowth, several databases including PubMed, Google Scholar, Medline, Embase, and Cochrane Database were searched using the following keywords: Alopecia, Hair loss, Hair growth, Low level laser therapy, Low level light therapy, Low energy laser irradiation, and Photobiomodulation. From the searches, 21 relevant studies were summarized in this review including 2 in vitro, 7 animal, and 12 clinical studies. Among clinical studies, only five were randomized controlled trials (RCTs), which evaluated LLLT effect on male and female pattern hair loss. The RCTs were critically appraised using the created checklist according to the Critical Appraisal for Therapy Articles Worksheet created by the Center of Evidence-Based Medicine, Oxford. The results demonstrated that all the performed RCTs have moderate to high quality of evidence. However, only one out of five studies performed intention-to-treat analysis, and only another study reported the method of randomization and subsequent concealment of allocation clearly; all other studies did not include this very important information in their reports. None of these studies reported the treatment effect of factors such as number needed to treat. Based on this review on all the available evidence about effect of LLLT in alopecia, we found that the FDA-cleared LLLT devices are both safe and effective in patients with MPHL and FPHL who did not respond or were not tolerant to standard treatments. Future randomized controlled trials of LLLT are strongly encouraged to be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement to facilitate analysis and comparison.
Lasers Med Sci. 2015 Jun 6. [Epub ahead of print]

Evaluation of wavelength-dependent hair growth effects on low-level laser therapy: an experimental animal study.

Kim TH1, Kim NJ, Youn JI.

Author information

  • 1Department of Biomedical Engineering, College of Medical Science, Catholic University of Daegu, Gyeongsan, 712-702, South Korea.

Abstract

In this study, we aimed to investigate the wavelength-dependent effects of hair growth on the shaven backs of Sprague-Dawley rats using laser diodes with wavelengths of 632, 670, 785, and 830 nm. Each wavelength was selected by choosing four peak wavelengths from an action spectrum in the range 580 to 860 nm. The laser treatment was performed on alternating days over a 2-week period. The energy density was set to 1.27 J/cm2for the first four treatments and 1.91 J/cm2 for the last four treatments. At the end of the experiment, both photographic and histological examinations were performed to evaluate the effect of laser wavelength on hair growth. Overall, the results indicated that low-level laser therapy (LLLT) with a 830-nm wavelength resulted in greater stimulation of hair growth than the other wavelengths examined and 785 nm also showed a significant effect on hair growth.

Expert Opin Drug Discov. 2015 Feb 9:1-24. [Epub ahead of print]

Drug discovery for alopecia: gone today, hair tomorrow.

Santos Z1, Avci P, Hamblin MR.

Author information

  • 1Massachusetts General Hospital, Wellman Center for Photomedicine , Boston, MA 02114 , USA +1 617 726 6182 ; +1 617 726 6643 ; hamblin@helix.mgh.harvard.edu.

Abstract

Introduction: Hair loss or alopecia affects the majority of the population at some time in their life, and increasingly, sufferers are demanding treatment. Three main types of alopecia (androgenic [AGA], areata [AA] and chemotherapy-induced [CIA]) are very different, and have their own laboratory models and separate drug-discovery efforts. Areas covered: In this article, the authors review the biology of hair, hair follicle (HF) cycling, stem cells and signaling pathways. AGA, due to dihydrotesterone, is treated by 5-? reductase inhibitors, androgen receptor blockers and ATP-sensitive potassium channel-openers. AA, which involves attack by CD8+NK group 2D-positive (NKG2D+) T cells, is treated with immunosuppressives, biologics and JAK inhibitors. Meanwhile, CIA is treated by apoptosis inhibitors, cytokines and topical immunotherapy.

Expert opinion: The desire to treat alopecia with an easy topical preparation is expected to grow with time, particularly with an increasing aging population. The discovery of epidermal stem cells in the HF has given new life to the search for a cure for baldness. Drug discovery efforts are being increasingly centered on these stem cells, boosting the hair cycle and reversing miniaturization of HF. Better understanding of the molecular mechanisms underlying the immune attack in AA will yield new drugs. New discoveries in HF neogenesis and low-level light therapy will undoubtedly have a role to play.

Lasers Surg Med. 2014 Oct; 46(8): 601–607.
Published online 2014 Aug 13. doi:  10.1002/lsm.22277

The growth of human scalp hair in females using visible red light laser and LED sources

Raymond J Lanzafame, ND, MBA,1,* Raymond R Blanche, BS,2 Richard P Chiacchierini, PhD,3 Eric R Kazmirek, BS,4and Jeffrey A Sklar, MD5

 

* Correspondence to: Raymond J. Lanzafame, MD, MBA, FACS, Raymond J. Lanzafame, MD PLLC, 757 Titus Avenue, Rochester, NY 14617-3930., E-mail: moc.liamg@emafaznal.dnomyar
Disclosures: This study was funded by Apira Science, Inc.
R. P. Chiacchierini, E. Kazmirek and J. A. Sklar have no disclosures. R. R. Blanche has received consulting fees, has had study related travel expenses paid and has ownership interest in Apira Science.
R. J. Lanzafame has received consulting fees, fees for manuscript preparation and has ownership interest in Apira Science. He is Editor-in-Chief of Photomedicine and Laser Surgery, on the Editorial Boards of General Surgery News, Journal of Laparoendoscopic Surgery, Journal of the Society of Laparoscopic Surgeons, and Lasers in Medical Science. He serves as a consultant to the General and Plastic Surgery Devices and other panels of the Medical Devices Advisory Committee of the FDA’s Center for Devices and Radiological Health. He performs medicolegal consulting for various law firms and entities. He serves as a consultant for various companies, including Business and venture capital groups including GLG Councils and others. He is member of the Board of Directors and Director of Continuing Medical Education for the American Society for Laser Medicine and Surgery. He is a partner in Biomedical Gateway, LLC, which was formed to seek grants in HIT, medical device development and research.
Contract grant sponsor: ClinicalTrials.gov Identifier; Contract grant number: NCT01437163.

 

Accepted 2014 Jul 7.

 

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.:

 

 

 

INTRODUCTION

Endre Mester first observed that mice treated with lasers during experiments investigating the potential carcinogenic effects of laser exposure regrew hair in shaved areas significantly faster than unexposed mice in 1967 1,2. Other investigators subsequently observed that some patients exhibited paradoxical hair growth at the periphery of areas treated with lasers for hair removal or adjacent to lesions treated with laser sources 35. These seminal observations stimulated others to investigate the potential effects and applications of low level laser (light) therapy (LLLT) in male and female pattern androgenetic alopecia 615.

We have previously reported the results of the male arm of a randomized controlled trial that was undertaken to define the safety and physiologic effects that occur when the hair follicle and surrounding tissue structures of the human scalp are exposed to LLLT using a bicycle helmet type device fitted with an array of laser and LED light sources operating at 655?nm 16. This laser system meets the requirements of an FDA Class 3R laser product, and as a non-medical laser system (RDW). The LED components are non-classified light sources when marketed for cosmetic applications, as is the case here. The device was granted an FDA 510k clearance for the treatment of males with Hamilton–Norwood IIa-V, or frontal patterns of hair loss, in patients with Fitzpatrick I–IV skin types based on the results for the male cohort of that trial 16,17.

The present investigation reports the results obtained for the female cohort of subjects treated under the TH655 study protocol.

MATERIALS AND METHODS

A clinical study was conducted as per the IRB approved TH655 protocol (Essex IRB, Lebanon, NJ). The trial was registered on www.ClinicalTrials.gov and was assigned the identifier NCT01437163. Forty-seven healthy female volunteers 18–60 years old were recruited at two IRB approved treatment sites.

Informed consent was obtained, and each female subject was screened to verify that she met the inclusion and exclusion criteria for the study. History and physical examinations were conducted. All 47 women had Fitzpatrick skin types I–IV and Ludwig–Savin Baldness Scale I–II (L-S I-2, I-3, I-4, II-1, II-2) baldness patterns. An area of scalp was selected in a transition zone at the vertex of the scalp at a site determined by the investigator. The hairs within the selected site were trimmed to a maximum height of 3?mm in area that was approximately 2.5?cm in diameter. The area was marked with a medical tattoo using green ink using aseptic technique.

The site was then photographed using a custom camera apparatus that consisted of a Canon Rebel T3i 18 Megapixel camera system (Canon USA, Melville, NY) equipped with a Tamron 60?mm f/2 Macro lens with 1:1 magnification (Tamron USA, Commack, NY). A 55?mm Lens attachment ring was used to affix a Promaster RL60 LED Ring Light (Promaster, Inc, Fairfield, CT). The camera system was mounted to a custom Stand-off device which was manually positioned onto the scalp surface by the investigator each time photographs were taken. Images were taken positioning the tattoo in the center of the frame. These baseline images were coded and then forwarded to the photographic consultant. The photographic consultant verified that the images were of acceptable quality and processed the images for transmission to the investigator responsible for conducting the hair counts. The transmitted images were masked using a black mask to produce a 1.9?cm diameter circle centered on the tattoo, which provided a consistent 2.85?cm2 area for hair counts. Neither the photographic consultant nor the investigator performing the hair counts was aware of the identity of the subject or the subjects’ study group assignment.

Subjects were randomly assigned to active treatment or placebo treatment groups. Each subject received a numbered “TOPHAT655” unit (Apira Science, Inc, Boca Raton, FL) which was distributed to her by the Project Manager, who also provided instructions for the care and use of the device. The patients, the treating physicians, the photographic consultant, and the investigator performing the hair counts were not aware whether the device was a therapeutic (active) device or a functioning placebo (sham). The investigational devices did not have corporate logos or other identifiers, with the exception of a study investigational device number. A serial number was assigned to each helmet, which was recorded in a device log that contained the reference code for placebo and actual test unit. This log was not revealed to any investigator, subject, office staff, hair counter or sponsor employee.

The active treatment group received a “TOPHAT 655” unit containing 21, 5?mW laser diodes and 30 LEDS both operating at 655?nm (655?±?5?nm and 655?±?20?nm, respectively) and providing constant illumination over the scalp under the apparatus. Each subject self-treated at home for 25?minutes per treatment session every other day for 16 weeks (60 treatments, 67?J/cm2 delivered irradiance, and 2.9?J per treatment session).

The sham group received a unit that was identical in appearance and function to the laser group devices, with the exception that the light sources were incandescent wheat lights that were painted red to mimic the appearance and configuration of the functioning device. Each subject in the sham group self-treated at home for 25?minutes/treatment, every other day for 16 weeks (60 treatments). Incandescent sources were substituted 1:1 for each laser diode and LED source position on the sham helmet’s interior.

The light output of the active treatment and sham treatment devices was determined using an Ophir Nova Display Power Meter equipped with a Model 30A-P-R-SH detector head (Ophir-Spiricon, LLC, Logan, UT). The active devices delivered an energy density of 67?J/cm2 at 655?nm per 25?minute treatment session at the level of the scalp. The placebo units delivered no measurable light at scalp level. The active device design was such that constant illumination was delivered over the areas of the scalp covered by the device.

The operating temperatures of the active and placebo devices were matched and were measured using a Klein Tools Model IR 3000 Thermometer (Klein Tools, Lincolnshire, IL). The temperature of the units was 27.8?±?0.3°C at the level of the electronics and 22.2?±?0.3°C on the interior surface of the helmet.

Study treatments were self-administered as follows: The subject’s head was self-positioned within the helmet, until a sensor triggered the start of therapy. There was no contact between the subject and the light-emitting device; only the light reaches the subject scalp. Treatment duration was set to 25?minutes. The lasers and LEDs automatically shut off after the treatment session was complete. All device function was controlled by a hand set that was actuated by the user subject once the power cord was plugged into a standard 120?volt outlet and the start button was pressed. All other functions were pre-programmed and automatic. A full set of user instructions accompanied each helmet. There was no pre or post treatment care required, only that subjects’ hair must be clean and not contain spray or gel fixative agents. No safety eyewear was required during the treatment sessions. A complete demonstration of the proper use of the helmet was provided to each subject at the time the test units were distributed. Periodic subject monitoring was conducted by telephone. Subjects were queried relative to their use of the device and for any possible side effects or adverse events.

The subjects returned at 16 weeks for follow up and post treatment photography of the previously marked area. The area was again trimmed and photographed using the same apparatus and photographic conditions as at the initial (baseline) visit. The images were processed, transmitted and analyzed in the same fashion as was the case for the pretreatment photographs.

One pre-treatment (baseline) and one post-treatment image were counted for each subject. The number of terminal hairs present in the masked area was counted and recorded.

Data analysis was conducted by a consulting statistician, who was provided the raw data and who was blinded as to identify the subjects and their individual treatments. The primary endpoint for evaluation was the percent increase in hair counts from baseline at the end of 16 weeks of treatment. The percent increase from baseline is to be obtained by the following formula:

equation image

 

A data pooling analysis was done to determine whether there was a site by treatment interaction in the percent increase. An analysis of variance was done with only site, treatment group, and site by treatment group interaction in the model and the interaction was not statistically significant. The data were pooled across both sites to arrive at an estimate of the effect for the primary endpoint. Univariate tests comparing the Sham and Active treatment groups were by Wilcoxon rank-sum tests, and an unequal variance t-test was performed.

RESULTS AND STATISTICAL ANALYSIS

Study Site Subject Distribution

The study was a blinded multicenter study. The study subjects were allocated to Active Treatment or Sham on a 1:1 basis at each of two study sites. The distribution of study subjects by random treatment assignment and study site are given in Table?Table11.

Table 1

Subjects, Treatment Assignments, and Study Sites

A total of 47 patients were enrolled in the study and completed baseline screening and photography. However, three subjects at site one and two subjects from site two withdrew from the study prior to the initiation of treatment. Thus there were 24 active treatment and 18 sham subjects available for analysis at the end of the study after 16 weeks of treatment.

There were no reported side effects or adverse events reported by any subject or site at any time during the conduct of the study.

Baseline Demographic Characteristics

There was information gathered on three important demographic characteristics, subject age, subject Fitzpatrick Skin Type, and Ludwig–Savin Baldness Scale. The results of these characteristics by treatment group are presented in the Table?Table22.

Table 2

Baseline Demographic Characteristics by Treatment Group

Note that age was not statistically significant by treatment group nor was it significant by study site (P?=?0.0320). Neither Fitzpatrick skin type nor the Ludwig–Savin Baldness Scale differed by treatment group. Both study sites differed by Fitzpatrick Skin Type (P?<?0.001) and by Ludwig–Savin Baldness Scale (P?<?0.001).

Hair Counts and Photography

Photographs of the selected scalp site were taken prior to any treatment (baseline) and the same site was again photographed after the final treatment had been performed (post-treatment).

Examples of baseline (pre treatment) and final (post treatment) images are presented in Figures 1 and ?and2.2. Figure 1 demonstrates the results for typical patients in the placebo or sham group. Note that there is only a slight change present in the images taken at 16 weeks as compared to the baseline images. Figure 2demonstrates baseline and final images for typical subjects in the active treatment group. A significant increase in the number of terminal hairs present is evident in the 16 week photographs compared to baseline. The diameter of the hairs present in the sample areas was not measured.

Fig 1

Sham treatment group subject pre and post treatment image examples. Hair counts for subject A were 151 at baseline and 166 post treatment. Hair counts for subject B were 41 at baseline and 44 post treatment.

Fig 2

Active treatment group subject pre and post treatment image examples. Hair counts for subject A were 153 at baseline and 221 post treatment. Hair counts for subject B were 108 at baseline and 209 post treatment.

Baseline Hair Counts

The analyses reported below were conducted in Minitab 16 (Minitab, Inc, State College, PA). The raw data for these analyses appear in Appendix 1.

The baseline hair counts by treatment group and study site are presented in Table?Table3.3. While the two study sites differ in the absolute values for the mean baseline hair counts, there was no statistical difference between the mean hair counts in the active and sham group subjects at the particular study center. An analysis of variance was done with only site, treatment group, and site by treatment group interaction in the model and the interaction was not statistically significant (P?=?0.812).The study site was used as a possible covariate in the multivariable analyses performed below.

Table 3

Baseline Hair Counts of Vertex Scalp Site

Primary Analysis

The primary endpoint was the percent increase in hair counts from baseline at the end of 16 weeks of treatment (60 treatments). The percent increase from baseline was obtained for each subject by using the formula above.

A data pooling analysis was done to determine if there was a site by treatment interaction in the percent increase. If the interaction between site and treatment was significant with a P?<?0.15, there would be evidence of a site by treatment interaction that would require weighting the site results to get an estimate of the study effect. An analysis of variance was done with only site, treatment group, and site by treatment group interaction in the model and the interaction was not statistically significant (P?=?0.812). Thus the data were pooled across both sites to arrive at an estimate of the effect for the primary endpoint.

Univariate tests comparing the Sham and Active Treatment groups were intended to be by Wilcoxon rank-sum tests unless the variance between the two groups was statistically significantly different. In that case, the comparison was to be conducted by an unequal variance t-test. The results of the pooled data analysis appear in Table?Table44.

Table 4

Baseline Hair Counts, End of Study Hair Counts, and Percent Increase by Treatment Group

These results indicate that the univariate result comparing the increase in hair counts was statistically significant (P?=?0.001). Low level laser treatment for 16 weeks increased mean hair counts by about 37% relative to sham treatment using the study device and the study treatment parameters. A multivariable analysis accounting for baseline differences in hair counts by study site indicates that the percent increase by treatment adjusted for study site indicate that the study site had a non-significant impact on the percent (P?=?0.218). Therefore the study site differences in baseline counts did not modify the effect of treatment on the percent increase in hair counts after treatment. A second supportive multivariable analysis used baseline count as a covariate and in that analysis, the baseline term was not significant (P?=?0.627), treatment was highly significant (P?<?0.0001), but study site was not statistically significant (P?=?0.219). Further, when age, Fitzpatrick type and Ludwig–Savin scale were included in a third sensitivity model, none were statistically significant with P-values of 0.901, 0.939, and 0.538, respectively. Thus, the univariate result is confirmed by the multivariable analysis with active LLLT treatment as the only significant term in the model (P?<?0.001).

DISCUSSION

Treatment of androgenetic alopecia with LLLT has been studied in humans and in animal models using a variety of light sources, wavelengths and treatment parameters 69,11,12,1416,18. We previously reported the results of the TH655 RCT using the so-called TOPHAT 655 device in males with androgenetic alopecia 16.

The present study details the results of the female arm of the same study protocol, which was initiated and completed after the male study was concluded. These investigations employed a randomized, double-blind design and used a true placebo via a helmet identical in appearance to the active device, with incandescent sources that glowed red but did not deliver measurable light to the subject’s scalp and which operated at a temperature of 22.2?±?0.3°C. Neither the active nor the sham devices delivered thermal energy to the scalp. Treatments were passive and did not depend on the user for delivery, aside from the subject being required to place the unit on the scalp and activate the controller.

Increases in hair counts were also observed in the sham or placebo group in the present study as was also the case in the earlier male cohort 16. These observations may represent a true placebo effect, since the sham device did not deliver thermal energy or measurable light at scalp level. However, seasonal variations in hair growth or other factors could be the basis for this observation.

Avci et al. recently reviewed the use of LLLT for the treatment of hair loss 18. They note that phototherapy is assumed to stimulate anagen re-entry in telogen hair follicles, prolong the duration of the anagen phase, increase the rates of proliferation in active anagen hair follicles and prevent premature catagen development18. They discuss several possible mechanisms for the photobiomodulation effect observed in these cases 18.

One such theory is that LLLT, particularly at wavelengths in the red range as was used in this investigation, affects the functioning of the stem cells that cause hair growth 16,18. LLLT activates cytochrome c oxidase and increases mitochondrial electron transport 1927, which leads to an increase in ATP and subsequent reversal of hair follicles from the dormant telogen stage of growth, to the active growth or anagen stage6,7,9,11,13,14,16,18.

There is a growing body of evidence that the use of LLLT for the purpose of promoting hair growth is both safe and effective in both men and women. The optimal wavelengths and treatment parameters for treatment of alopecia remain indeterminate at this time. There is a need to conduct further studies in order to determine the potential role for near infrared and/or combinations of wavelengths as well as to investigate the effects of parameters such as coherence, pulsing and treatment frequency on clinical outcomes. The present study was not designed to investigate alternative treatment regimes or parameters. It was designed to evaluate the safety and effectiveness of a particular device designed for home use with specific parameters on the treatment of women with androgenetic alopecia.

We have demonstrated that the use of low level laser therapy at 655?nm applied to the scalp every other day for 16 weeks (60 treatments) via the TOPHAT 655 device resulted in a significant improvement in women who used the device. There was a 37% increase in terminal hair counts in the active treatment group as compared to the control (sham) group (P?<?0.001) in 18–60 year old female subjects with I-2, I-3, I-4, II-1, or II-2 Ludwig–Savin baldness patterns and Fitzpatrick I–IV Skin Types. These results mirror those of the previously reported male trial which demonstrated a 35% increase in males with Hamilton–Norwood IIa-V baldness patterns and Type I–IV Fitzpatrick Skin Types 16.

Similarly, the female subjects were able to conduct the treatments at home and were able to apply and use the device as directed without any side effects or adverse events being reported at any time during the conduct of the study. This indicates that the device is safe for the unsupervised environment of home use and that the therapy is easily managed by both men and women using this device.

SUMMARY

The present study demonstrates that that low level laser (light) treatment of the scalp every other day for 16 weeks using the TOPHAT 655 device is a safe and effective treatment for androgenic alopecia in healthy women between the ages of 18–60 with Fitzpatrick Skin Types I–IV and Ludwig–Savin Baldness Scale I-2–II-2 baldness patterns. Subjects receiving LLLT at 655?nm achieved a 37% increase in hair counts as compared to sham treated control patients in this multicenter RCT. These results are similar to those reported in an earlier study using the same device in males with alopecia.

Appendix A

Raw Hair Counts by Study Site and Treatment Group.

Subjecta Site Treatment Age (yrs) Fitzpatrick Skin Type Ludwig Savin Scale BaselineHair Count Posttrtb Diffc Pct_basd
1 1 Active 43 1 I 483 687 204 42.236
2* 1 27 1 II
3 1 Sham 57 3 I 292 297 5 1.712
4* 1 45 1 I
5 1 Sham 44 2 I 494 471 ?23 ?4.656
6 1 Active 52 1 I 245 333 88 35.918
7 1 Active 57 1 I 244 358 114 46.721
8* 1 49 3 I
9 1 Sham 57 1 II 130 150 20 15.385
10 1 Active 50 1 II 249 334 85 34.137
11 1 Sham 33 1 I 560 636 76 13.571
12 1 Sham 58 3 II 262 311 49 18.702
13 1 Active 52 3 II 268 450 182 67.910
14 1 Active 52 2 I 260 354 94 36.154
15 1 Active 44 2 I 599 829 230 38.397
16 1 Sham 53 1 II 167 170 3 1.796
17 2 Active 44 3 I 228 375 147 64.474
18 2 Active 51 3 II 234 385 151 64.530
19 2 Active 50 3 II 145 221 76 52.414
20 2 Active 47 3 I 182 276 94 51.648
21 2 Active 33 3 II 153 221 68 44.444
22 2 Active 26 3 II 192 263 71 36.979
23 2 Active 56 3 II 148 203 55 37.162
24 2 Active 45 2 I 108 209 101 93.519
25 2 Active 44 3 II 53 57 4 7.547
26 2 Active 38 2 II 144 230 86 59.722
27 2 Active 51 3 II 152 265 113 74.342
28 2 Active 58 2 II 110 139 29 26.364
29 2 Active 53 3 II 225 340 115 51.111
30 2 Active 58 3 I 97 146 49 50.515
31 2 Sham 60 3 I 41 44 3 7.317
32 2 Sham 51 3 I 224 248 24 10.714
33 2 Sham 59 3 II 116 140 24 20.690
34 2 Sham 45 2 II 209 249 40 19.139
35 2 Sham 46 3 I 327 342 15 4.587
36 2 Sham 54 3 II 250 358 108 43.200
37 2 Sham 53 3 II 135 149 14 10.370
38 2 Sham 42 3 II 232 248 16 6.897
39* 2 20 3 I
40 2 Sham 53 3 II 262 270 8 3.053
41 2 Sham 52 3 I 61 60 ?1 ?1.639
42 2 Active 28 4 I 204 328 124 60.784
43 2 Sham 55 2 II 151 166 15 9.934
44* 2 27 3 II
45 2 Sham 46 3 II 194 229 35 18.041
46 2 Active 31 4 I 183 264 81 44.262
47 2 Active 48 2 II 124 171 47 37.903
aPatient numbers were grouped for convenience not by order of presentation or randomization.
bPsttrt is the hair count after 16 weeks of treatment.
cDiff?=?Psttrt – Baseline Hair Count.
dPct_bas is the percent hair increase (decrease) at 16 weeks as a percent of baseline.
*Five subjects withdrew from the study after enrollment and prior to treatment.

REFERENCES

1. Mester E, Szende B, Gärtner P. Die Wirkung der Laserstrahlen auf den Haarwwuchs der Maus. Rad Biol Ther; 1967;9/5:621–626. [PubMed]
2. Mester E, Szende B, Tota JG. Effect of laser on hair growth in mice. Kiserl Orvostud. 1967;19:628–631.
3. Bernstein EF. Hair growth induced by diode laser treatment. Dermatol Surg. 2005;31:584–586. [PubMed]
4. Lolis MS, Marmur ES. Paradoxical effects of hair removal systems: A review. J Cosmet Dermatol.2006;5:274–276. [PubMed]
5. Willey A, Torrontegui J, Azpiazu J, Landa N. Hair stimulation following laser and intense pulsed light photo- epilation: Review of 543 cases and ways to manage it. Lasers Surg Med. 2007;39:297–301.[PubMed]
6. Avram MR, Leonard RT, Jr, Epstein ES, Williams JL, Bauman AJ. The current role of laser/light sources in the treatment of male and female pattern hair loss. J Cosmet Laser Ther. 2007;9:27–28. [PubMed]
7. Avram MR, Rogers NE. The use of low-level light for hair growth: Part I. J Cosmet Laser Ther.2009;11:110–117. [PubMed]
8. Stillman L. Reply to: The use of low-level light for hair growth: Part I. J Cosmet Laser Ther. 2010;12:116.[PubMed]
9. Bouzari N, Firooz AR. Lasers may induce terminal hair growth. Dermatol Surg. 2006;32:460. [PubMed]
10. Chung PS, Kim YC, Chung MS, Jung SO, Ree CK. The effect of low-power laser on the murine hair growth. J Korean Soc Plastic Reconstruct Surg. 2004;31:1–8.
11. Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Invest. 2009;29:283–292. [PubMed]
12. Yamazaki M, Miura Y, Tsuboi R, Ogawa H. Linear polarized infrared irradiation using Super Lizer is an effective treatment for multiple-type alopecia areata. Intl J Dermatol. 2003;42:738–740. [PubMed]
13. Shukla S, Sahu K, Verma Y, Rao KD, Dube A, Gupta PK. Effect of helium-neon laser irradiation on hair follicle growth cycle of Swiss albino mice. Skin Pharmacol and Physiol. 2010;23:79–85. [PubMed]
14. Satino JL, Markou M. Hair regrowth and increased hair tensile strength using the HairMax LaserComb for low-level laser therapy. Int J Cosmet Surg Aesth Dermatol. 2003;5:113–117.
15. Trelles MA, Mayayo E, Cisneros JL. Tratamiento de la alopecia areata con laser HeNe. Investigacion Y Clinica Laser. 1984;1:15–17.
16. Lanzafame RJ, Blanche RR, Bodian AB, Chiacchierini RP, Fernandez-Obregon Kazmirek ER. The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lasers Surg Med.2013;45(8):487–495. [PubMed]
18. Avci P, Gupta GK, Clark J, Wikonkal N, Hamblin MR. Low-Level Laser (Light) Therapy (LLLT) for treatment of hair loss. Lasers Surg Med. 2014;46:144–151. [PMC free article] [PubMed]
19. Passarella S, Casamassima E, Molinari S, Pastore D, Quagliariello E, Catalano IM, Cingolani A. Increase of proton electrochemical potential and ATP synthesis in rat liver mitochondria irradiated in vitro by helium-neon laser. FEBS Lett. 1984;175(1):95–99. [PubMed]
20. Yu W, Naim JO, McGowan M, Ippolito K, Lanzafame RJ. Photomodulation of oxidative metabolism and electron chain enzymes in rat liver mitochondria. Photochem. Photobiol. 1997;66(6):866–871. [PubMed]
21. Karu TI. The science of low power laser therapy. London Gordon and Breach Sci. Publ. 1998:14–33.53–94, 95–121.
22. Karu TI. Primary and secondary mechanisms of action of visible to near–IR radiation on cells. J. Photochem. Photobiol, B. 1998;49(1):1–17. [PubMed]
23. Vladimiorv IA, Klebanov GI, Borisenko GG, Osipov AN. Molecular and cellular mechanisms of the low intensity laser radiation effect. Biofizika. 2004;49(2):339–350. [PubMed]
24. Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004;4(5–6):559–567. [PubMed]
25. Karu TI. Low power laser therapy. In: Vo-Dinh T, editor. Biomedical Photonics Handbook. 48. CRC Press; 2003. pp. 1–25.
26. Liu TCY, Jiao JL, Xu XY, Liu XG, Deng SX, Liu SH. Photobiomodulation: Phenomenology and its mechanism. SPIE Proc. 2004;5632:185–191.
27. Hamblin MR, Demidova TN. Mechanisms of low level light therapy. SPIE Proc. 2006;6140:1–12.
Skinmed. 2014 May-Jun;12(3):145-7.

Low-level laser/light therapy for androgenetic alopecia.

Gupta AK, Lyons DC, Abramovits W.

Abstract

Androgenetic alopecia (AGA) is a persistent and pervasive condition that affects men worldwide. Some common treatment options for AGA include hair prosthetics, oral and topical medications, and surgical hair restoration (SHR). Pharmaceutical and SHR treatments are associated with limitations including adverse side effects and significant financial burden. Low-level laser or light (LLL) devices offer alternative treatment options that are not typically associated with adverse side effects or significant costs. There are clinic- and home-based LLL devices. One home-based laser comb device has set a standard for others; however, this device requires time devoted to carefully moving the comb through the hair to allow laser penetration to the scalp. A novel helmet-like LLL device for hair growth has proven effective in preliminary trials and allows for hands-free use. Regardless, there are few clinical trials that have been conducted regarding LLL devices for AGA and results are mixed. Further research is required to establish the true efficacy of these devices for hair growth in comparison to existing alternative therapies.

Int J Trichology. 2014 Apr;6(2):45-9. doi: 10.4103/0974-7753.138584.

Use of low-level laser therapy as monotherapy or concomitant therapy for male and female androgenetic alopecia.

Munck A1, Gavazzoni MF1, Trüeb RM2.

Author information

  • 1Institute of Dermatology Prof. R.D. Azulay, Rio de Janeiro, Brazil.
  • 2Center for Dermatology and Hair Diseases, Bahnhofplatz, Wallisellen, Switzerland.

Abstract

BACKGROUND:

Androgenetic alopecia (AGA) is the most common form of hair loss in men and in women. Currently, minoxidil and finasteride are the treatments with the highest levels of medical evidence, but patients who exhibit intolerance or poor response to these treatments are in need of additional treatment modalities.

OBJECTIVE:

The aim was to evaluate the efficacy and safety of low-level laser therapy (LLLT) for AGA, either as monotherapy or as concomitant therapy with minoxidil or finasteride, in an office-based setting.

MATERIALS AND METHODS:

Retrospective observational study of male and female patients with AGA, treated with the 655 nm-HairMax Laser Comb(®), in an office-based setting. Efficacy was assessed with global photographic imaging.

RESULTS:

Of 32 patients (21 female, 11 male), 8 showed significant, 20 moderate, and 4 no improvement. Improvement was seen both with monotherapy and with concomitant therapy. Improvement was observed as early as 3 months and was sustained up to a maximum observation time of 24 months. No adverse reactions were reported.

CONCLUSIONS:

LLLT represents a potentially effective treatment for both male and female AGA, either as monotherapy or concomitant therapy. Combination treatments with minoxidil, finasteride, and LLLT may act synergistic to enhance hair growth.

J Dermatolog Treat. 2014 Apr;25(2):162-3. doi: 10.3109/09546634.2013.832134. Epub 2013 Oct 9.

The use of lowlevel light therapy in the treatment of androgenetic alopecia and female pattern hair loss.

Gupta AK1, Daigle D.

Author information

  • 1Department of Medicine, University of Toronto , Toronto , Canada.
  • Abstract

Androgenetic alopecia (AGA) or female pattern hair loss (FPHL) is the most common form of hair loss in men and women. Despite its common occurrence, our understanding of the etiology of AGA and FPHL remains incomplete. As such, traditional therapies demonstrate modest efficacies and new therapies continue to be sought. Lowlevel light therapy (LLLT) is a relatively new technique used to promote hair growth in both men and women with AGA and FPHL. Currently, there exist several LLLT devices marketed for the treatment of alopecia, which claim to stimulate hair growth; yet marketing these devices only requires that safety, not efficacy, be established. A handful of studies have since investigated the efficacy of LLLT for alopecia with mixed results. These studies suffered from power, confounding and analysis issues which resulted in a high risk of bias in LLLT studies. Due to the paucity of well-conducted randomized controlled trials, the efficacy of LLLT devices remains unclear. Randomized controlled trials of LLLT conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement would greatly increase the credibility of the evidence and clarify the ambiguity of the effectiveness of LLLT in the treatment of AGA and FPHL.

Lasers Med Sci. 2013 May;28(3):701-6. doi: 10.1007/s10103-012-1139-7. Epub 2012 Jun 14.

Lowlevel laser treatment accelerated hair regrowth in a rat model of chemotherapy-induced alopecia (CIA).

Wikramanayake TC1, Villasante AC, Mauro LM, Nouri K, Schachner LA, Perez CI, Jimenez JJ.

Author information

  • 1Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Avenue, RSMB 2023A, Miami, FL 33136, USA.

Abstract

Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of antineoplastic chemotherapy for which there is no effective interventional approach. A lowlevel laser (LLL) device, the HairMax LaserComb®, has been cleared by the FDA to treat androgenetic alopecia. Its effects may be extended to other settings; we have demonstrated that LaserComb treatment induced hair regrowth in a mouse model for alopeciaareata. In the current study, we tested whether LLL treatment could promote hair regrowth in a rat model for CIA. Chemotherapy agents cyclophosphamide, etoposide, or a combination of cyclophosphamide and doxorubicin were administered in young rats to induce alopecia, with or without LLL treatment. As expected, 7-10 days later, all the rats developed full body alopecia. However, rats receiving laser treatment regrew hair 5 days earlier than rats receiving chemotherapy alone or sham laser treatment (with the laser turned off). The accelerated hair regrowth in laser-treated rats was confirmed by histology. In addition, LLL treatment did not provide local protection to subcutaneously injected Shay chloroleukemic cells. Taken together, our results demonstrated that LLL treatment significantly accelerated hair regrowth after CIA without compromising the efficacy of chemotherapy in our rat model. Our results suggest that LLL should be explored for the treatment of CIA in clinical trials because LLL devices for home use (such as the HairMax LaserComb®) provide a user-friendly and noninvasive approach that could be translated to increased patient compliance and improved efficacy

Lasers Med Sci.  2012 Jun 14. [Epub ahead of print]

Low-level laser treatment accelerated hair regrowth in a rat model of chemotherapy-induced alopecia (CIA).

Wikramanayake TC, Villasante AC, Mauro LM, Nouri K, Schachner LA, Perez CI, Jimenez JJ.

Source

Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Avenue, RSMB 2023A, Miami, FL, 33136, USA.

Abstract

Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of antineoplastic chemotherapy for which there is no effective interventional approach. A low-level laser (LLL) device, the HairMax LaserComb®, has been cleared by the FDA to treat androgenetic alopecia. Its effects may be extended to other settings; we have demonstrated that LaserComb treatment induced hair regrowth in a mouse model for alopecia areata. In the current study, we tested whether LLL treatment could promote hair regrowth in a rat model for CIA. Chemotherapy agents cyclophosphamide, etoposide, or a combination of cyclophosphamide and doxorubicin were administered in young rats to induce alopecia, with or without LLL treatment. As expected, 7-10 days later, all the rats developed full body alopecia. However, rats receiving laser treatment regrew hair 5 days earlier than rats receiving chemotherapy alone or sham laser treatment (with the laser turned off). The accelerated hair regrowth in laser-treated rats was confirmed by histology. In addition, LLL treatment did not provide local protection to subcutaneously injected Shay chloroleukemic cells. Taken together, our results demonstrated that LLL treatment significantly accelerated hair regrowth after CIA without compromising the efficacy of chemotherapy in our rat model. Our results suggest that LLL should be explored for the treatment of CIA in clinical trials because LLL devices for home use (such as the HairMax LaserComb®) provide a user-friendly and noninvasive approach that could be translated to increased patient compliance and improved efficacy.

Lasers Med Sci.  2011 Jul 9. [Epub ahead of print]

Effects of the Lexington LaserComb on hair regrowth in the C3H/HeJ mouse model of alopecia areata.

Wikramanayake TC, Rodriguez R, Choudhary S, Mauro LM, Nouri K, Schachner LA, Jimenez JJ.

Source

Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, 1600 NW 10th Avenue, RSMB 2023A, Miami, FL, 33136, USA.

Abstract

Alopecia areata (AA) is a common autoimmune disease that presents with non-scarring alopecia. It is characterized by intra- or peri-follicular lymphocytic infiltrates composed of CD4+ and CD8+ T-cells on histology. To this day, few treatments are effective for AA. Here we present findings of using a low-level laser comb to alleviate the symptoms of AA in a C3H/HeJ mouse model for AA. Fourteen C3H/HeJ mice with induced AA were used in this study. Two were killed to confirm AA through histology. The remaining 12 mice were randomized into two groups; group I received HairMax LaserComb (wavelength: 655 nm, beam diameter <5 mm; divergence 57 mrad; nine lasers) for 20 s daily, three times per week for a total of 6 weeks; group II was treated similarly, except that the laser was turned off (sham-treated). After 6 weeks of LaserComb treatment, hair regrowth was observed in all the mice in group I (laser-treated) but none in group II (sham-treated). On histology, increased number of anagen hair follicles was observed in laser-treated mice. On the other hand, sham-treated mice demonstrated hair follicles in the telogen phase with no hair shaft. LaserComb seems to be an effective and convenient device for the treatment of AA in the C3H/HeJ mouse model. Human studies are required to determine the efficacy and safety of this device for AA therapy.

Skin Pharmacol Physiol. 2010;23(2):79-85. Epub 2009 Dec 14.

Effect of helium-neon laser irradiation on hair follicle growth cycle of Swiss albino mice.

Shukla S, Sahu K, Verma Y, Rao KD, Dube A, Gupta PK.

Laser Biomedical Applications and Instrumentation Division, Raja Ramanna Centre for Advanced Technology, Indore, India. sunita_agni@yahoo.com.in

Abstract

We report the results of a study carried out to investigate the effect of helium-neon (He-Ne) laser (632.8 nm) irradiation on the hair follicle growth cycle of testosterone-treated and untreated mice. Both histology and optical coherence tomography (OCT) were used for the measurement of hair follicle length and the relative percentage of hair follicles in different growth phases. A positive correlation (R = 0.96) was observed for the lengths of hair follicles measured by both methods. Further, the ratios of the lengths of hair follicles in the anagen and catagen phases obtained by both methods were nearly the same. However, the length of the hair follicles measured by both methods differed by a factor of 1.6, with histology showing smaller lengths. He-Ne laser irradiation (at approximately 1 J/cm(2)) of the skin of both the control and the testosterone-treated mice was observed to lead to a significant increase (p < 0.05) in % anagen, indicating stimulation of hair growth. The study also demonstrates that OCT can be used to monitor the hair follicle growth cycle, and thus hair follicle disorders or treatment efficacy during alopecia.

South Med J. 2010 Sep;103(9):917-21. doi: 10.1097/SMJ.0b013e3181ebcf71.

Types of hair loss and treatment options, including the novel lowlevel light therapy and its proposed mechanism.

Ghanaat M.

Author information

  • Department of Dermatology, SUNY Downstate Medical Center, Brooklyn, NY, USA. mahyar.ghanaat@downstate.edu

Abstract

Androgenetic alopecia (AGA) is the most common form of hair loss in men, and female pattern hair loss (FPHL) is the most common form of hair loss in women. Traditional methods of treating hair loss have included minoxidil, finasteride, and surgical transplantation. Currently there is a myriad of new and experimental treatments. In addition, lowlevel light therapy (LLLT) has recently been approved by the United States Food and Drug Administration (FDA) for the treatment of hair loss. There are several theories and minimal clinical evidence of the safety and efficacy of LLLT, although most experts agree that it is safe. More in vitro studies are necessary to elucidate the mechanism and effectiveness at the cellular level, and more controlled studies are necessary to assess the role of this new treatment in the general population.

Pediatr Dermatol. 2009 Sep-Oct;26(5):547-50.

 

308-nm excimer laser for the treatment of alopecia areata in children

Al-Mutairi N.

Department of Dermatology, Farwaniya Hospital, Farwaniya, Kuwait. nalmut@usa.net

Alopecia areata (AA) is a common skin disease which is characterized by nonscarring localized or diffused hair loss. In this study we assessed the efficacy of 308-nm Excimer laser in the treatment of alopecia areata in children. A total of 9 children with 30 recalcitrant patches alopecia areata and two children with alopecia areata totalis were enrolled in this study which included seven male and four female patients, aged between 4 and 14 years and the durations of their disease were between 7 and 25 months. All of these patients had more than one lesion of alopecia areata and at least one of them was left as a control for comparison. The lesions were treated with the 308-nm Excimer laser twice a week for a period of 12 weeks. Regrowth of hair was observed in 18 (60%) alopecia patches in the scalp, while there was no response in the control patches and over the extremities. Only four patients with scalp lesions showed a recurrence of alopecia after 6 months post laser therapy. So, 308-nm Excimer laser is considered an effective safe therapeutic option for patchy alopecia areata in children.

Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.

HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial.

Leavitt M1, Charles G, Heyman E, Michaels D.

Author information

  • 1Private Dermatology Practice, Maitland, Florida, USA. mlleavitt@aol.com

Abstract

BACKGROUND AND OBJECTIVE:

The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributedlaser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laserbeams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).

METHODS:

This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source.

RESULTS:

Of the 110 patients who completed the study, subjects in the HairMax LaserComb treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups.

CONCLUSIONS:

The results of this study suggest that the HairMax LaserComb is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

J Cosmet Laser Ther. 2009 Jun;11(2):110-7

The use of low-level light for hair growth: part I.

 

Avram MR, Rogers NE.

Cornell Department of Dermatology, New York, NY, USA. dochair@aol.com

BACKGROUND AND OBJECTIVE: Low-level laser therapy (LLLT) is a new therapy for the treatment of hair loss. It has received enormous media attention and tremendous marketing budgets from companies that sell the devices, but no independent, peer-reviewed studies have demonstrated its efficacy in this application. Here we investigate the efficacy of LLLT in enhancing hair growth.

METHODS: A total of seven patients were exposed to LLLT twice weekly for 20 minutes each time over a period of 3-6 months. Five patients were treated for a total of 3 months and two were treated for 6 months. Videomicroscopic images were taken at baseline, 3 months, and 6 months, and analyzed for changes in vellus hair counts, terminal hair counts, and shaft diameter. Both videomicroscopic and global images underwent blinded review for evidence of subjective improvement. Patients also answered questionnaires assessing hair growth throughout the study. Neither patients nor physicians conducting the study received any financial compensation.

RESULTS: The results indicate that on average patients had a decrease in the number of vellus hairs, an increase in the number of terminal hairs, and an increase in shaft diameter. However, paired i-testing indicated that none of these changes was statistically significant. Also, blinded evaluation of global images did not support an improvement in hair density or caliber.

CONCLUSIONS: LLLT may be a promising treatment option for patients who do not respond to either finasteride or minoxidil, and who do not want to undergo hair transplantation. This technology appears to work better for some people than for others. Factors predicting who will most benefit are yet to be determined. Larger, longer-term placebo-controlled studies are needed to confirm these findings, and demonstrate statistical significance, or refute them altogether.

Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.

HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial.

Leavitt M, Charles G, Heyman E, Michaels D.

Private Dermatology Practice, Maitland, Florida, USA.

The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb(R) is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb(R) laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA). This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb(R) or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source. Of the 110 patients who completed the study, subjects in the HairMax LaserComb(R) treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb(R) was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups. The results of this study suggest that the HairMax LaserComb(R) is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

Semin Cutan Med Surg. 2008 Dec;27(4):292-300

Current and future trends in home laser devices.

Hodson DS.

Department of Cutaneous Laser Surgery, Brooke Army and Wilford Hall Air Force Medical Centers, San Antonio, TX, USA. darrylhodson@hotmail.com

Laser and intense pulse light procedures, once limited to physician offices and operating rooms, have become increasingly available at a variety of nonmedical sites such as spas. State regulations as to whom can perform these treatments varies greatly across the United States and, thus, in some states, the operators of these devices do not have any significant additional medical or laser knowledge more so than the patients who receive treatment. Although serious complications of laser treatments occur, they are rare when the procedure is performed correctly. Currently, there are 2 light devices approved by the Food and Drug Administration for home hair removal on the U.S. market, and several other companies are expected to release products in the near future. There are two home laser devices marketed for hair loss. As these light-based devices become smaller, safer, easier to use, as well as cheaper to manufacture, direct use by patients will increase. Results from home use devices are impressive but still inferior to office-based lasers and light devices. It is likely that home lasers and intense pulsed light devices will eventually receive other indications because many of these devices use wavelengths similar to currently available office based equipment.

Facial Plast Surg. 2008 Nov;24(4):414-27. Epub 2008 Nov 25.

Understanding and management of female pattern alopecia.

Leavitt M.

Medical Hair Restoration, Maitland, Florida.

Female pattern hair loss is devastating to many of the 21 million U.S. women who suffer from it. It is essential to differentiate female pattern hair loss from other types of hair loss to ensure appropriate treatment. Through use of follicular units, follicular families, and follicular pairing between existing hair follicles, natural-looking results can be achieved in women. Hair transplants create the benefit of increasing density and providing options for hair styling and can be combined with medications, devices, and styling aids such as minoxidil, low-level laser therapy, and topical powder makeup, respectively.

J Cosmet Laser Ther. 2006 Apr;8(1):27-30.

Use of the pulsed infrared diode laser (904 nm) in the treatment of alopecia areata.

Waiz M, Saleh AZ, Hayani R, Jubory SO.

Department of Dermatology and Venereology, Baghdad Teaching Hospital, Baghdad, Iraq. raafahayani@yahoo.com

BACKGROUND: Alopecia areata is a rapid and complete loss of hair in one or several patches, usually on the scalp, affecting both males and females equally. It is thought to be an autoimmune disease which is treated with different modalities with variable success. Laser treatment of different wavelengths has been used in the management of this problem.

OBJECTIVE: To study the effect of the pulsed infrared diode laser (904 nm) in the treatment of alopecia areata.  Methods. Sixteen patients with 34 resistant patches that had not responded to different treatment modalities for alopecia areata were enrolled in this study. In patients with multiple patches, one patch was left as a control for comparison. Patients were treated on a four-session basis, once a week, with a pulsed diode laser (904 nm) at a pulse rate of 40/s. A photograph was taken of each patient before and after treatment.

RESULTS: The treated patients were 11 males (68.75%) and five females (31.25%). Their ages ranged between 4 and 50 years with a mean of 26.6+/-SD of +/-13.8, and the durations of their disease were between 12 months and 6 years with a mean of 13.43+/-SD of +/-18.34. Regrowth of hair was observed in 32 patches (94%), while only two patches (6%) failed to show any response. No regrowth of hair was observed in the control patches. The regrowth of hair appeared as terminal hair with its original color in 29 patches (90.6%), while three patches (9.4%) appeared as a white villous hair. In patients who showed response, the response was detected as early as 1 week after the first session in 24 patches (75%), while eight patients (25%) started to show response from the second session.

CONCLUSION: The pulsed infrared diode laser is an effective mode of therapy with a high success rate for resistant patches of alopecia areata.

Dermatol Surg. 2005 May;31(5):584-6.

Hair growth induced by diode laser treatment.

Bernstein EF.

Laser Surgery and Cosmetic Dermatology Centers, Bryn Mawr, Pennsylvania, USA. dermguy@hotmail.com

BACKGROUND: Although hair reduction by long-pulsed red and infrared lasers and light sources is generally quite effective, paradoxical hair growth has rarely been observed following treatment.

OBJECTIVE: To report a case of thick hair growth following 810 nm diode laser treatment and its subsequent treatment.

METHODS. A 24-year-old man who had previously had laser hair reduction on his posterior neck was treated to a test area on his upper back.

RESULTS: Thick terminal hair developed in the treated area subsequent to laser treatment. Further treatment of this area removed the terminal hair but resulted in terminal hair growth in an annular distribution surrounding the treatment site.

CONCLUSIONS: Diode laser treatment rarely stimulates terminal hair growth. This phenomenon should be studied to better understand hair growth cycles and to help develop more effective treatments for hair loss and hair growth

THE LOW INTENSIVE LASER THERAPY OF ALOPECIA

Nikiforova N. B.

Municipal Polyclinic, Vladivostok, Russia

Recently a great deal of men and women suffer from quantitative and qualitative disorders of hair growth of diverse etiology. Based on the property of low intensive laser radiation to activize substantially the microcirculation and to enhance metabolic and regulate neurohumoral processes, the author seeks to normalize by means of laser circulation the functioning of hairy follicle and to reduce degeneration-dystrophic processes in derma which result in disorder of hair regeneration. Therapeutic laser apparatus with the wavelength of 0,63 and 0,89 mm were used for the treatment. A course of therapy consists of 10-15 procedures. Depending on a complication of the disease a patient underwent 1 to 3 courses with the intervals of 1, 3 and 6 months. 78 patients (17 men and 61 women) at the age of 16 to 49 years old have been treated. Diseases have been caused by strong stresses, after-effects of surgical treatment, ovary and thyroid gland dysfunctions, gastroenteric diseases etc. A considerable improvement of hair quality, recovery of pigment, increase in thickness and rate of hair growth (50-100%) were observed in all cases. An intensive alopecia was ceased among 100% of patients. By the end of the first course a daily number of fallen hairs was in accordance with the norm. By the end of the third week an appearance of new hairs was observed along the front line of growth in 90% of patients. Out of 24 patients underwent three medical treatments the problem was completely solved for 23 of them. The effectiveness of laser method in the treatment of alopecia is confirmed

Int J Dermatol. 2003 Sep;42(9):738-40.

Linear polarized infrared irradiation using Super Lizer is an effective treatment for multiple-type alopecia areata.

Yamazaki M, Miura Y, Tsuboi R, Ogawa H.

Department of Dermatology, Juntendo University School of Medicine, Tokyo, Japan. yamazaki@med.juntendo.ac.jp

BACKGROUND: Super Lizer trade mark is a linear polarized light instrument, which has been used with good effect in orthopedics and anesthesiology to treat arthralgia and neuralgia with a high output of infrared radiation.

AIM: To test Super Lizer trade mark ‘s efficacy for the treatment of alopecia areata.

METHODS: Fifteen patients over 18 years of age, diagnosed with alopecia areata and displaying symptoms of patchy hair loss, were topically irradiated with infrared radiation using the Super Lizer trade mark. The patients were irradiated intermittently for an interval of 3 min once every week or every 2 weeks.

RESULTS: Seven of 15 (46.7%) of the irradiated areas showed hair regrowth 1.6 months earlier than the nonirradiated areas (chi2 official approval, P = 0.003). With regard to adverse effects caused by Super Lizer trade mark treatment, only one patient complained of a sensation of heat in the irradiated area.

CONCLUSIONS: These findings suggest that Super Lizer trade mark, with its noninvasive properties, is a useful apparatus for the treatment of mild forms of alopecia areata.