In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
95
Therapeutics Clinical Research
San Diego, California, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
DermResearch, Inc.
Austin, Texas, United States
Change in Target Area Hair Count (TAHC)
Changes from Baseline in TAHC \[in number of non-vellus hairs\] using digital image analysis at Month 6.
Time frame: Baseline and Month 6
Subject Self Assessment (Hair Growth Assessment [HGA])
The subject's evaluation of treatment benefit via the HGA questionnaires at Month 6. Scalp hair growth is compared from baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Time frame: Month 6
Change in Target Area Hair Width (TAHW)
Changes from Baseline in TAHW \[in μm/cm2\] using digital image analysis at Month 6.
Time frame: Baseline and Month 6
Change in Target Area Hair Density (TAHD)
Changes from Baseline in TAHD \[in intensity units\] using digital image analysis at Month 6.
Time frame: Baseline and Month 6
Subject evaluation of treatment benefit via the Hair Growth Index (HGI) and Hair Growth Satisfaction Scale (HGSS) questionnaires
The subject's evaluation of treatment benefit via the HGI and HGSS questionnaires at Month 6. HGI: Hair growth is compared from baseline by three questions on a health outcome questionnaire, which are scored using the following 7-point scale: much less (-3), moderately less (-2), slightly less (-1), the same amount (0), slightly more (1), moderately more (2), much more (3). HGSS: Hair appearance/growth is compared from baseline by five questions, which are scored using the following 7-point scale: very dissatisfied (-3), dissatisfied (-2), somewhat dissatisfied (-1), neutral/neither satisfied nor dissatisfied (0), somewhat satisfied (1), satisfied (2), very satisfied (3).
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Time frame: Month 6
Investigator's Global Assessment (IGA)
Compared to Baseline, the investigator will assess the subject's scalp hair growth using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
Time frame: Baseline, Month 2, 4 and 6