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Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA
Sponsor: Pelage Pharmaceuticals, Inc.
Summary
The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2024-06-05
Completion Date
2025-10-01
Last Updated
2026-09-22
Healthy Volunteers
Yes
Conditions
Interventions
PP405 0.05% Topical Gel
Medicated topical gel containing PP405 0.05%, applied once daily to the scalp
Topical Vehicle Gel
Vehicle = placebo topical gel
Locations (8)
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
DermResearch
Austin, Texas, United States
Stride Clinical Research LLC
Sugar Land, Texas, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States