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NCT05910450 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
A Phase 3 study of Alopecia, Androgenetic, sponsored by Cassiopea SpA.
- Active
- Registry status
- Phase 3
- Development phase
- 703
- Enrollment target
- 20
- Study locations
NCT05910450: Active Phase 3 study of Alopecia, Androgenetic, sponsored by Cassiopea SpA.
NCT05910450 is a Phase 3 study of Alopecia, Androgenetic that is active but no longer recruiting, run by Cassiopea SpA. The registered enrollment target is 703 participants, above the 116-participant average among 3 other Alopecia, Androgenetic trials with a reported enrollment target (506% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05910450, a Phase 3 study of Alopecia, Androgenetic, is active but no longer recruiting, sponsored by Cassiopea SpA.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 703 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Changes from Pivotal Part 1 Baseline in non-vellus Total Area Hair Count (TAHC) at Month 6.
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 |
What the registry record for NCT05910450 still lists
NCT05910450 is an interventional study that assigns participants to a tested intervention. The registered 703 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 3 other Alopecia, Androgenetic trials with a reported enrollment target (506% higher).
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.
NCT05910450 names 20 study sites across 12 states, led by Other, Texas, Florida.
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.
What interventions are being tested in trial NCT05910450?
The interventions under investigation include: Clascoterone 5% solution (DRUG), Vehicle solution (DRUG).
Who is sponsoring clinical trial NCT05910450?
This trial is sponsored by Cassiopea SpA, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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