A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2/3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia
Pelage Pharmaceuticals, Inc.
Summary
The study is designed to validate efficacy and long term safety of PP405.
Description
Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.
Eligibility
- Age range
- 18–55 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent. 2. Able and willing to provide written informed consent 3. Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening. 4. Have a modified Norwood-Hamilton score of Type IV or Type V 5. Agree to comply with protocol procedures Exclusion Criteria: 1. Concomitant diagnosis of non-AGA forms of alopecia. 2. Use of other hair loss treatments within periods specified in protocol. 3. Use of excluded medications and procedures as specified in protocol. 4. Diagnosi…
Interventions
- DrugPP405 0.05% Topical Gel
Medicated topical gel containing PP405 0.05%
- DrugVehicle Topical Gel
Topical gel
Locations (17)
- Johnson DermatologyFort Smith, Arkansas
- Burke Pharmaceutical ResearchHot Springs, Arkansas
- Ablon Skin Institute and Research CenterManhattan Beach, California
- Clinical Trials Research InstituteThousand Oaks, California
- Skin Research Institute, LLCCoral Gables, Florida
- MOORE Clinical Research, Inc.Tampa, Florida