Condition: Alopecia, Androgenetic · Sponsor: Cassiopea SpA
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 la…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Investigate MD | Scottsdale, Arizona, United States | — |
| Physician's Institute of Cosmetic and Reconstructive Surgery | Hollywood, Florida, United States | — |
| DelRicht Research | Atlanta, Georgia, United States | — |
| Revival Research Institute | Troy, Michigan, United States | — |
| Grekin Skin Institute | Warren, Michigan, United States | — |
| DelRicht Research | Wildwood, Missouri, United States | — |
| Piedmont Plastic Surgery and Dermatology | Huntersville, North Carolina, United States | — |
| Advanced Dermatology & Cosmetic Surgery | Spartanburg, South Carolina, United States | — |
| DelRicht Research | Thompson's Station, Tennessee, United States | — |
| Austin Institute for Clinical Research | Pflugerville, Texas, United States | — |
| Acclaim Dermatology LLC | Sugar Land, Texas, United States | — |
| Premier Clinical Research | Spokane, Washington, United States | — |
+ 15 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05914805