Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO
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|ClinicalTrials.gov Identifier: NCT02528552|
Recruitment Status : Unknown
Verified November 2016 by Theradome, Inc..
Recruitment status was: Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : December 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Device: LH80 PRO Device: Sham Device||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Randomized, Controlled, Double-blind Study That Evaluates a Low Level Laser Therapy Over-the-counter at Home Device, Theradome™ LH80 PRO vs a Sham Device, for Promoting Hair Growth in Males Diagnosed With Androgenetic Alopecia|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: LH80 PRO
Low level laser therapy
Device: LH80 PRO
Sham Comparator: Sham device
No low level laser therapy
Device: Sham Device
- Hair growth [ Time Frame: 26 weeks ]Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).
- Quantitative Hair Growth [ Time Frame: 26 weeks ]Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).
- Subject Self Assessment [ Time Frame: 26 weeks ]Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.
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): NCT02528552
|United States, California|
|Axis Clinical Tirals|
|Los Angeles, California, United States, 90036|
|United States, Georgia|
|Newnan, Georgia, United States, 30263|
|United States, Oregon|
|NW Dermatology & Research Center, LLC|
|Portland, Oregon, United States, 97210|
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|