- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947505
Treatment of Androgenetic Alopecia in Males
A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve 45 male 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 Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment 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
-
-
Florida
-
Palm Beach, Florida, United States, 33409
- Abe Marcadis, M.D.
-
-
Texas
-
Austin, Texas, United States, 78759
- Michael Jarratt, MD
-
-
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
- Norwood-Hamilton IIa to V
- Active hair loss within last 12 months
Exclusion Criteria:
- Photosensitivity to laser light
- Malignancy in the target area
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 |
---|---|
Active Comparator: HairMax LaserComb 2009, 7 Beam
Lower level laser phototherapy medical device with 7 laser beams
|
Device application 3 times week (non-consecutive days), for 26 weeks
Other Names:
|
Active Comparator: Control Device
Identical to the Active device, but with 7 LED's instead of lasers
|
Device application 3 times week (non-consecutive days), for 26 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Time Frame: 16 and 26 weeks
|
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16.
Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
|
16 and 26 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Jarratt, M.D., DermaResearch, Inc.
- Principal Investigator: Abe Marcadis, M.D., Palm Beach Research Center
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
- 7 2009-M-01
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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