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NCT02503137 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Androgenetic Alopecia, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 5
- Study locations
NCT02503137: Completed Phase 2 study of Androgenetic Alopecia, sponsored by Biosplice Therapeutics.
NCT02503137 is a Phase 2 study of Androgenetic Alopecia that has completed, run by Biosplice Therapeutics. The registered enrollment target is 49 participants, below the 162-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (70% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02503137, a Phase 2 study of Androgenetic Alopecia, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of terminal hair follicles over the treatment period.
Conditions Studied
Interventions
- DRUG Topical SM04554 solution
- DRUG Topical Vehicle solution
Study Locations (5)
Texas
- Research Site - College Station
- Research Site - Houston
Michigan
- Research Site - Clinton Township
Ohio
- Research Site - Cleveland
Virginia
- Research Site - Lynchburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT02503137 record still lists
NCT02503137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 162-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Androgenetic Alopecia appearing as the primary indexed condition, and to 2 interventions - of which Topical SM04554 solution is the first listed.
NCT02503137 lists 5 locations in 4 states (Texas, Michigan, Ohio).
Frequently Asked Questions
What is clinical trial NCT02503137 about?
NCT02503137 is a clinical study titled "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". 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...
What is the current status of trial NCT02503137?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2015-08. Estimated completion is 2016-04.
What conditions does trial NCT02503137 study?
This clinical trial studies the following conditions: Androgenetic Alopecia.
What interventions are being tested in trial NCT02503137?
The interventions under investigation include: Topical SM04554 solution (DRUG), Topical Vehicle solution (DRUG).
Who is sponsoring clinical trial NCT02503137?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02503137 being conducted?
This trial has 5 study locations across Michigan, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Androgenetic Alopecia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02503137's enrollment target sits among peer trials
49 9th of 16 higher than 8 of 16 other Androgenetic Alopecia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Androgenetic Alopecia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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