Completed

A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia

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What is being tested

PP405 0.05% Topical Gel

+ PP405 Topical Vehicle Gel

Drug
Who is being recruted

Alopecia+4

+ Hair Diseases

+ Hypotrichosis

From 18 to 55 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorPelage Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 5, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore a new treatment option for adults experiencing androgenetic alopecia, which is a common form of hair loss that affects both men and women. The study aims to evaluate the safety, how the body processes the drug, and how effective the new treatment, called PP405, might be for improving hair growth. Understanding these aspects is important because current treatments for hair loss can be limited or not effective for everyone. By exploring new options, this trial hopes to offer better solutions for individuals dealing with this condition. Participants in this study will be randomly assigned to receive either the new treatment, PP405, or a placebo, which is a substance with no active ingredients, to compare the results. The treatment will be administered in a controlled way, ensuring that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is referred to as a "double-blind" study. Throughout the trial, researchers will monitor participants to assess how safe the treatment is and how it affects hair growth, providing valuable data on its potential benefits and any possible side effects.

Official TitleA Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
NCT06393452
Principal SponsorPelage Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

78 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPathological Conditions, Anatomical

Criteria

4 inclusion criteria required to participate
Agree to comply with protocol procedures
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.
5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
0.05% Topical Gel applied once daily

Group II

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

Group III

Placebo
Placebo Topical Gel applied once daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Stride Clinical Research LLC

Sugar Land, United StatesOpen Stride Clinical Research LLC in Google Maps
Suspended

Jordan Valley Dermatology Center

South Jordan, United States
Suspended

Virginia Clinical Research, Inc.

Norfolk, United States
Suspended

California Dermatology & Clinical Research Institute

Encinitas, United States
Completed8 Study Centers