Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Phase 2

Active, not recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: PP405 0.05% Topical Gel; Drug: PP405 Topical Vehicle Gel

• Registration Number: NCT06393452
• Lead Sponsor: Pelage Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-01
• Study Start: 2024-06-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Male or female subjects aged 18 to 55 years.
2. Able and willing to provide written informed consent.
3. Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
4. 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 as specified in protocol.
4. Diagnosis of other medical conditions as specified in protocol.
5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PP405 0.05% Topical Gel	PP405 0.05% Topical Gel	0.05% Topical Gel applied once daily
PP405 Topical Vehicle Gel	PP405 Topical Vehicle Gel	Placebo Topical Gel applied once daily
PP405 0.05% Topical Gel - Open Label Extension	PP405 0.05% Topical Gel	0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with treatment-related adverse events	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE	Collection of adverse events, treatment emergent adverse events and serious adverse events.
Change in local dermal tolerability as assessed by subject and investigator	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE	Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of PP405	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE	To assess the concentration of PP405 in plasma

Trial Locations

Locations (8)

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

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