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COMPLETED 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

NCT02503137 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 49 participants
Start Date 2015-08
Est. Completion 2016-04
Phase Phase 2

Sponsor

Biosplice Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02503137

The ClinicalTrials.gov registry entry for NCT02503137 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02503137 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02503137?

The interventions under investigation include: Topical SM04554 solution (DRUG), Topical Vehicle solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02503137?

This trial is sponsored by Biosplice Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial