Androgenetic Alopecia Clinical Trial
Official title:
A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females
Verified date | August 2012 |
Source | Lexington International, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
Status | Completed |
Enrollment | 72 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of androgenetic alopecia - Fitzpatrick Skin Types I-IV - Ludwig I-4, II-1, II-2, or frontal - Active hair loss within last 12 months Exclusion Criteria: - Photosensitivity to laser light - Malignancy in the target area - Pregnancy - Lactating females |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | David Goldberg, MD | Hackensack | New Jersey |
United States | Janet Hickman, MD | Lynchburg | Virginia |
United States | Jose Mendez, DO | Miami | Florida |
United States | Sadick Research Group | New York | New York |
United States | Abe Marcadis, MD | Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Lexington International, LLC |
United States,
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 Investig. 2009;29(5):283-92. doi: 10.2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline | The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance. | Baseline, 16 weeks, 26 weeks | No |
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