Treatment of Androgenetic Alopecia in Females, 12 Beam
|Androgenetic Alopecia Hair Loss Female Pattern Baldness||Device: HairMax LaserComb 2009 model 12 beam Device: Sham Device|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females|
- Change in Hair Count at 16 and 26 Weeks Over Baseline [ Time Frame: Baseline, 16 weeks, 26 weeks ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham Device
Device: Sham Device
Active Comparator: LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
Device: HairMax LaserComb 2009 model 12 beam
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 63 female subjects, who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.
Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016964
|United States, Florida|
|University of Miami Miller School of Medicine - Dermatology|
|Miami, Florida, United States, 33136|
|United States, Minnesota|
|University of Minnesota, Department of Dermatology|
|Minneapolis, Minnesota, United States, 55455|
|United States, Ohio|
|Cleveland Clinic Foundation - Department of Dermatology|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Maria Hordinsky, M.D.||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Wilma Bergfeld, M.D.||The Cleveland Clinic|
|Principal Investigator:||Lawrence Schachner, M.D.||University of Miami|