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NCT05914805 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
A Phase 3 study, sponsored by Cassiopea SpA.
- Completed
- Registry status
- Phase 3
- Development phase
- 762
- Enrollment target
NCT05914805 is a Phase 3 study that has completed, run by Cassiopea SpA. The registered enrollment target is 762 participants.
The verdict
NCT05914805, a Phase 3 study, has completed, sponsored by Cassiopea SpA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 762 participants
- Enrollment target
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
Interventions
- DRUG Clascoterone 5% solution
- DRUG Vehicle solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 762 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2025-07-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05914805
The ClinicalTrials.gov registry entry for NCT05914805 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 762 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cassiopea SpA, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clascoterone 5% solution is the first listed.
NCT05914805 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05914805 about?
NCT05914805 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)". 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 NCT05914805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 762 participants. The study started on 2023-08-17. Estimated completion is 2025-07-16.
What interventions are being tested in trial NCT05914805?
The interventions under investigation include: Clascoterone 5% solution (DRUG), Vehicle solution (DRUG).
Who is sponsoring clinical trial NCT05914805?
This trial is sponsored by Cassiopea SpA, which has 6 total clinical trials registered on ClinicalTrials.gov.
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