Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects who were randomized to vehicle in Part 1 will be eligible to participate in the Open-label Extension in Part 2 of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PP405 0.05% Topical Gel

0.05% Topical Gel applied once daily

Group Type ACTIVE_COMPARATOR

PP405 0.05% Topical Gel

Intervention Type DRUG

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

PP405 Topical Vehicle Gel

Placebo Topical Gel applied once daily

Group Type PLACEBO_COMPARATOR

PP405 Topical Vehicle Gel

Intervention Type DRUG

PP405 Vehicle = placebo

PP405 0.05% Topical Gel - Open Label Extension

0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension

Group Type OTHER

PP405 0.05% Topical Gel

Intervention Type DRUG

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

Interventions

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PP405 0.05% Topical Gel

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

Intervention Type DRUG

PP405 Topical Vehicle Gel

PP405 Vehicle = placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes