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NCT07819435PHASE2, PHASE3Recruiting

Phase 2/3 Efficacy and Safety of PP405 in Adult Males

Pelage Pharmaceuticals, Inc.

Start Date

9/21/2026

Completion Date

6/1/2028

Summary

The study is designed to validate efficacy and long term safety of PP405.

Detailed Description

Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.

Eligibility Criteria

Age Range: 18 years to 55 years

Inclusion Criteria: 1. Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent. 2. Able and willing to provide written informed consent 3. Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening. 4. Have a modified Norwood-Hamilton score of Type IV or Type V 5. 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 and procedures 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.

Interventions

DRUG

PP405 0.05% Topical Gel

DRUG

Vehicle Topical Gel

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Androgenetic Alopecia

Locations

AllerVie Clinical Research

Birmingham, Alabama 35209

United States

Johnson Dermatology

Fort Smith, Arkansas 72916

United States

Burke Pharmaceutical Research

Hot Springs, Arkansas 71913

United States

Ablon Skin Institute and Research Center

Manhattan Beach, California 90266

United States

Clinical Trials Research Institute

Thousand Oaks, California 91230

United States

Skin Research Institute, LLC

Coral Gables, Florida 33146

United States

MOORE Clinical Research, Inc.

Tampa, Florida 33607

United States

DelRicht Research (Experience Dermatology)

Atlanta, Georgia 30329

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46256

United States

Indiana Clinical Trials Center

Plainfield, Indiana 46168

United States

DelRicht Research @LA Dermatology Associates

Baton Rouge, Louisiana 70809

United States

Minnesota Clinical Study Center

New Brighton, Minnesota 55112

United States

DelRicht Research (Town Center Dermatology)

Wildwood, Missouri 63040

United States

Vitality Clinical Trials LLC

Woodbury, New York 11797

United States

Optima Research Boardman

Boardman, Ohio 441512

United States

DelRicht Research @Mt Pleasant Dermatology

Mt. Pleasant, South Carolina 29464

United States

AMR Clinical - Myrtle Beach

Myrtle Beach, South Carolina 29588

United States

Dermatology and Laser Surgery Center

Houston, Texas 77002

United States

Texas Dermatology & Laser Specialists

San Antonio, Texas 78218

United States

Jordan Valley Dermatology Center

South Jordan, Utah 84095

United States

Eurofins CRL Cosmetic LLC

Forest, Virginia 24551

United States

Innovaderm Research Inc

Montreal, Quebec H2X2V1

Canada