This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Axis Clinical Tirals
Los Angeles, California, United States
MedaPhase, Inc.
Newnan, Georgia, United States
NW Dermatology & Research Center, LLC
Portland, Oregon, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Hair growth
Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).
Time frame: 26 weeks
Quantitative Hair Growth
Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).
Time frame: 26 weeks
Subject Self Assessment
Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.
Time frame: 26 weeks
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