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NCT06393452 | ACTIVE NOT RECRUITING | Androgenetic Alopecia

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA
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.

Condition or disease

Androgenetic Alopecia

Intervention/treatment

PP405 0.05% Topical Gel

PP405 Topical Vehicle Gel

Phase

PHASE2

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-06-05
Estimated Primary Completion Date : 2025-11
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Location Details

NCT06393452

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

California Dermatology & Clinical Research Institute

Encinitis, California, United States, 92024

Not yet recruiting

United States, California

Clinical Trials Research Institute

Thousand Oaks, California, United States, 91320

Not yet recruiting

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Not yet recruiting

United States, Minnesota

Minnesota Clinical Study Center

New Brighton, Minnesota, United States, 55112

Not yet recruiting

United States, Texas

DermResearch

Austin, Texas, United States, 78759

Not yet recruiting

United States, Texas

Stride Clinical Research LLC

Sugar Land, Texas, United States, 77479

Not yet recruiting

United States, Utah

Jordan Valley Dermatology Center

South Jordan, Utah, United States, 84095

Not yet recruiting

United States, Virginia

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States, 23502