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

Phase 3Not Yet RecruitingNCT07819435

Pelage Pharmaceuticals, Inc.600 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

600

Conditions

Androgenetic Alopecia

Interventions

PP405 0.05% Topical GelDRUG

Medicated topical gel containing PP405 0.05%

Vehicle Topical GelDRUG

Topical gel

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline in non-vellus target area hair count

Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex

Time frame: Week 24

Secondary Outcomes

Change from baseline in the Participant Assessment of Scalp Coverage

Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage

Time frame: Week 24

≥20% increase from baseline in non-vellus target area hair count

Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count

Time frame: week 24

Change from baseline in non-vellus target area hair count

Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex

Time frame: Week 12

Change from baseline in the Participant Assessment of Scalp Coverage

Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage

Time frame: Week 12

≥20% increase from baseline in non-vellus target area hair count

Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count

Time frame: week 12

Central Contacts

Lisa Sherman

CONTACT

213-218-3830 clinicaltrials@pelagepharma.com

Data from ClinicalTrials.gov

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