- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016964
Treatment of Androgenetic Alopecia in Females, 12 Beam
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 Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine - Dermatology
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota, Department of Dermatology
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation - Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham Device
Sham device
|
Sham Device
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Active Comparator: LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
|
HairMax LaserComb
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 16 weeks, 26 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12 2009-F-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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