Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Completed · Phase 2 · Has a placebo group

Conditions studied: Androgenetic Alopecia

In brief

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.

Key facts

Study ID

NCT06393452

Run by

Pelage Pharmaceuticals, Inc.

People needed

78

Starts

2024-06-05

Expected to finish

2025-10-01

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects aged 18 to 55 years.
• Able and willing to provide written informed consent.
• 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.
• Agree to comply with protocol procedures

You may not qualify if…

• Concomitant diagnosis of non-AGA forms of alopecia.
• Use of other hair loss treatments within periods specified in protocol.
• Use of excluded medications as specified in protocol.
• Diagnosis of other medical conditions as specified in protocol.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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