Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Last updated: February 4, 2025
Sponsor: Pelage Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hair Loss

Scalp Disorders

Male Pattern Baldness

Treatment

PP405 Topical Vehicle Gel

PP405 0.05% Topical Gel

Clinical Study ID

NCT06393452
PP405-2001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 IIIvertex, 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

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, wouldprevent the subject from participating in the study or might confound study results.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: PP405 Topical Vehicle Gel
Phase: 2
Study Start date:
June 05, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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

Connect with a study center

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • Clinical Trials Research Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • DermResearch

    Austin, Texas 78759
    United States

    Site Not Available

  • Stride Clinical Research LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

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