Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

NCT06393452 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PP405-2001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (20)

• Percentage of Subjects With Adverse Events

  An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase

  Baseline to Day 84 of the randomized portion of the study

• Percentage of Subjects With Adverse Events

  An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase

  Baseline to Day 84 of the open label extension portion of the study

• Change in Local Dermal Tolerability as Assessed by Subject and Investigator

  Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema

  Post-dose at day 28 of the randomized portion of the study

• Change in Local Dermal Tolerability as Assessed by Subject and Investigator

  Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema

  Post-dose at day 84 of the open label extension portion of the study

• Change From Baseline in Blood Pressure

  Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)

  Baseline to Day 84 of the randomized portion of the study

• Change From Baseline in Pulse Rate

  Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)

  Baseline to Day 84 of the randomized portion of the study

• Change From Baseline in Temperature

  Change from baseline in temperature in the safety analysis population (day 84 minus baseline)

  Baseline to Day 84 of the randomized portion of the study

• Change From Baseline in Respiratory Rate

  Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)

  Baseline to Day 84 of the randomized portion of the study

• Change From Baseline in Weight

  Change from baseline in weight in the safety analysis population (day 84 minus baseline)

  Baseline to Day 84 of the randomized portion of the study

• Change From Baseline in Blood Pressure

  Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)

  Baseline to Day 84 of the open label extension portion of the study

• Change From Baseline in Pulse Rate

  Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)

  Baseline to Day 84 of the open label extension portion of the study

• Change From Baseline in Temperature

  Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)

  Baseline to Day 84 of the open label extension portion of the study

• Change From Baseline in Respiratory Rate

  Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)

  Baseline to Day 84 of the open label extension portion of the study

• Change From Baseline in Weight

  Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)

  Baseline to Day 84 of the open label extension portion of the study

• Change From Baseline in Mean Electrocardiogram Heart Rate

  Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)

  Baseline to day 28 of the randomized portion of the study

• Change From Baseline in Electrocardiogram (ECG) Results

  Electrocardiograms results were compared to baseline (day 28 minus baseline)

  Baseline to day 28 of the randomized portion of the study

• Change From Baseline in Mean Electrocardiogram Heart Rate

  Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)

  Baseline to day 84 of the open label extension portion of the study

• Change From Baseline in Electrocardiograms (ECGs)

  Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)

  Baseline to day 84 of the open label extension portion of the study

• Abnormal Laboratory Values

  Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)

  Day 28 post baseline in the randomized portion of the study

• Abnormal Laboratory Values

  Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)

  Day 84 post baseline in the open label extension portion of the study

Secondary Outcomes (2)

• Pharmacokinetics of PP405

  Baseline to Day 28 of the randomized portion of the study

• Pharmacokinetics of PP405

  Baseline to Day 84 of the open label extension portion of the study

Study Arms (2)

PP405 0.05% Topical Gel

ACTIVE COMPARATOR

PP405 0.05% Topical Gel applied once daily for 28 days.

Drug: PP405 0.05% Topical Gel

Topical Vehicle Gel, then PP405 0.05% Topical Gel

PLACEBO COMPARATOR

Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension.

Drug: PP405 0.05% Topical Gel; Drug: Topical Vehicle Gel

Interventions

PP405 0.05% Topical Gel DRUG

Medicated topical gel containing PP405 0.05%, applied once daily to the scalp

Also known as: PP405 0.05%

PP405 0.05% Topical Gel; Topical Vehicle Gel, then PP405 0.05% Topical Gel

Topical Vehicle Gel DRUG

Vehicle = placebo topical gel

Also known as: Topical Placebo

Topical Vehicle Gel, then PP405 0.05% Topical Gel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pelage Pharmaceuticals, Inc.: lead

Study Sites (8)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Stride Clinical Research LLC

Sugar Land, Texas, 77479, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Christina Weng, MD Chief Medical Officer
• Organization: Pelage Pharmaceuticals

christina@pelagepharma.com

1 213-218-3830

Study Officials

• Christina Weng

  Pelage Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who were randomized to vehicle in Part 1 were eligible to participate in the Open-label Extension in Part 2 of the study and receive PP405 0.05% topical gel.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: June 5, 2024
• Primary Completion: July 16, 2025
• Study Completion: October 1, 2025
• Last Updated: September 22, 2026
• Results First Posted: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)