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COMPLETED
NCT06393452
PHASE2

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Sponsor: Pelage Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

PP405 0.05% Topical Gel

Medicated topical gel containing PP405 0.05%, applied once daily to the scalp

DRUG

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