Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study
Jimenez JJ, Wikramanayake TC, Bergfeld W, Hordinsky M, Hickman JG, Hamblin MR, Schachner LA
American journal of clinical dermatology · 131 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- University or hospital
- University of Minnesota
- Government
- National Institutes of Health
- Government
- National Institute of Allergy and Infectious Diseases
- Government
- NIAID NIH HHS
- Authors
- At least one author declares a financial tie to industry
- Grants
- National Institute of Allergy and Infectious Diseases (R01 AI050875); National Institutes of Health (R01AI050875)
Based on 4 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2014-01-28 · Am J Clin Dermatol · vol. 15 · issue 2 · pp. 115–127
- Publisher
- Adis, Springer Healthcare
- Cited
- 235 citations · more than 100% of similar papers · 19.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 39 works
- Access
- Open access (hybrid journal) · CC-BY-NC
- Research areas
- Hair Growth and Disorders · Dermatologic Treatments and Research · Laser Applications in Dentistry and Medicine
- Keywords
- Medicine, Scalp, Randomized controlled trial, Hair loss, Clearance, Clinical trial, Surgery, Internal medicine, Dermatology, Urology
- MeSH
- hair, humans, alopecia, prospective studies, double-blind method, adult, middle aged, female, male, low-level light therapy
7 authors
From US
- Joaquin Juan Jimenez · correspondingUniversity of Miami
- Tongyu Cao WikramanayakeUniversity of Miami
- Wilma Fowler BergfeldCleveland Clinic
- Maria Kramarczuk HordinskyUniversity of Minnesota
- Janet G. HickmanEducation & Research Foundation
- Michael R. HamblinHarvard University; Massachusetts General Hospital; Harvard–MIT Division of Health Sciences and Technology
Abstract
Significance
Male and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy.
Objective
To determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss.
Methods
Randomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged.
Results
Seventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam lasercomb-treated female subjects, 7-beam lasercomb-treated male subjects, and 9- and 12-beam lasercomb-treated male subjects, respectively, compared with 2.8 (p<0.0001), 3.0 (p<0.0001), 1.6 (p=0.0017), 9.4 (p=0.0249), and 9.4 (p=0.0028) in sham-treated subjects (95% confidence interval). The increase in terminal hair density was independent of the age and sex of the subject and the lasercomb model. Additionally, a higher percentage of lasercomb-treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects. No serious adverse events were reported in any subject receiving the lasercomb in any of the four trials.
Conclusions and relevance
We observed a statistically significant difference in the increase in terminal hair density between lasercomb- and sham-treated subjects. No serious adverse events were reported. Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men and women. Additional studies should be considered to determine the long-term effects of low-level laser treatment on hair growth and maintenance, and to optimize laser modality.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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