Recruiting
Phase 2
Phase 3

PP405

Sponsor:

Pelage Pharmaceuticals, Inc.

Code:

NCT07819435

Conditions

Androgenetic Alopecia

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

PP405 0.05% Topical Gel

Vehicle Topical Gel

Study Details

Brief summary:

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

Conditions

Androgenetic Alopecia

Study ID

NCT07819435

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PP405 0.05% Topical Gel

PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.

placebo comparator: Vehicle Topical Gel

Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52

Interventions

PP405 0.05% Topical Gel

Medicated topical gel containing PP405 0.05%

Vehicle Topical Gel

Topical gel

Primary outcome measure

  • Change from baseline in non-vellus target area hair count [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Lisa Sherman

213-218-3830clinicaltrials@pelagepharma.com

Locations

Johnson Dermatology

Recruiting

Fort Smith, Arkansas, United States, 72916

Burke Pharmaceutical Research

Recruiting

Hot Springs, Arkansas, United States, 71913

Ablon Skin Institute and Research Center

Recruiting

Manhattan Beach, California, United States, 90266

Clinical Trials Research Institute

Recruiting

Thousand Oaks, California, United States, 91230

Skin Research Institute, LLC

Recruiting

Coral Gables, Florida, United States, 33146

DelRicht Research (Experience Dermatology)

Recruiting

Atlanta, Georgia, United States, 30329

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46256

Indiana Clinical Trials Center

Recruiting

Plainfield, Indiana, United States, 46168

DelRicht Research @LA Dermatology Associates

Recruiting

Baton Rouge, Louisiana, United States, 70809

Minnesota Clinical Study Center

Recruiting

New Brighton, Minnesota, United States, 55112

DelRicht Research (Town Center Dermatology)

Recruiting

Wildwood, Missouri, United States, 63040

Dermatology and Laser Surgery Center

Recruiting

Houston, Texas, United States, 77002

Texas Dermatology & Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Jordan Valley Dermatology Center

Recruiting

South Jordan, Utah, United States, 84095

Eurofins CRL Cosmetic LLC

Recruiting

Forest, Virginia, United States, 24551

Innovaderm Research Inc

Recruiting

Montreal, Quebec, Canada, H2X2V1

More Information

Sponsor

Pelage Pharmaceuticals, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Pelage Pharmaceuticals, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.