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A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
NCT05910450 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests o
Conditions Studied
Interventions
- DRUG Clascoterone 5% solution
- DRUG Vehicle solution
Study Locations (20)
Other
- LTD Health — Batumi
- JSC Curatio — Tbilisi
- Kanveni National Center of Dermatology and Venerology — Tbilisi
- Tbilisi Cancer Center — Tbilisi
Texas
- DermResearch — Austin
- DelRicht Research — Frisco
- Progressive Clinical Research — San Antonio
Florida
- Mayo Clinic, Department of Dermatology — Jacksonville
- University of Miami — Miami
Louisiana
- DelRicht Research — Baton Rouge
- DelRicht Research — New Orleans
New York
- Diane S. Berson MD, PLLC — New York
- Derm Research Center of New York, Inc. — Stony Brook
Arkansas
- The Petrus Center for Aesthetic Surgery and Hair Transplantation — North Little Rock
California
- Therapeutics Clinical Research — San Diego
Michigan
- Henry Ford Health — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 703 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05910450
The ClinicalTrials.gov registry entry for NCT05910450 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 703 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cassiopea SpA, which has 3 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 Alopecia, Androgenetic appearing as the primary indexed condition, and to 2 interventions — of which Clascoterone 5% 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: NCT05910450 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Texas, Florida. 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 NCT05910450 about?
NCT05910450 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss". The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 part...
What is the current status of trial NCT05910450?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 703 participants. The study started on 2023-06-21. Estimated completion is 2026-06.
What conditions does trial NCT05910450 study?
This clinical trial studies the following conditions: Alopecia, Androgenetic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05910450?
The interventions under investigation include: Clascoterone 5% solution (DRUG), Vehicle solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05910450?
This trial is sponsored by Cassiopea SpA, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05910450 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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