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Completed

NCT Number: NCT06393452

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

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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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Dermatology & Clinical Research Institute, Encinitas, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects aged 18 to 55 years.
  • Able and willing to provide written informed consent.
  • 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.
  • Agree to comply with protocol procedures

Exclusion criteria

  • Concomitant diagnosis of non-AGA forms of alopecia.
  • Use of other hair loss treatments within periods specified in protocol.
  • Use of excluded medications as specified in protocol.
  • Diagnosis of other medical conditions as specified in protocol.
  • 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.

Treatment and study plan

PP405 0.05% Topical Gel

Drug

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

PP405 Topical Vehicle Gel

Drug

PP405 Vehicle = placebo

Primary outcomes

  1. Percentage of subjects with treatment-related adverse events

    Time frame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

    Collection of adverse events, treatment emergent adverse events and serious adverse events.

  2. Change in local dermal tolerability as assessed by subject and investigator

    Time frame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

    Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe)

Secondary outcomes

  1. Pharmacokinetics of PP405

    Time frame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

    To assess the concentration of PP405 in plasma

Sponsors and collaborators

Lead sponsor

Pelage Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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