A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing
NCT02503137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2020-02-17
Summary
This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of SM04554.
Conditions
Interventions
- DRUG
-
Topical SM04554 solution
- DRUG
-
Topical Vehicle solution
Sponsors & Collaborators
-
Biosplice Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Yusuf Yazici, M.D. · Biosplice Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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