Treatment of Androgenetic Alopecia in Females, 12 Beam
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|ClinicalTrials.gov Identifier: NCT01016964|
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : September 7, 2012
Last Update Posted : September 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia Hair Loss Female Pattern Baldness||Device: HairMax LaserComb 2009 model 12 beam Device: Sham Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Wilma Bergfeld, M.D.||The Cleveland Clinic|
|Principal Investigator:||Lawrence Schachner, M.D.||University of Miami|