Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: PP405 0.05% Topical Gel; Drug: Topical Vehicle Gel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch
    • Sugar Land, Texas, United States, 77479
      • Stride Clinical Research LLC
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PP405 0.05% Topical Gel; PP405 0.05% Topical Gel applied once daily for 28 days.	Drug: PP405 0.05% Topical Gel; Medicated topical gel containing PP405 0.05%, applied once daily to the scalp; Other Names: PP405 0.05%
Placebo Comparator: Topical Vehicle Gel, then PP405 0.05% Topical Gel; 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; Medicated topical gel containing PP405 0.05%, applied once daily to the scalp; Other Names: PP405 0.05%; Drug: Topical Vehicle Gel; Vehicle = placebo topical gel; Other Names: Topical Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of PP405	To assess the concentration of PP405 in plasma	Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
Pharmacokinetics of PP405	To assess the concentration of PP405 in plasma	Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84

Collaborators and Investigators

• Sponsor: Pelage Pharmaceuticals, Inc.
• Investigators: Study Chair: Christina Weng, Pelage Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Gels
• Other Study ID Numbers: PP405-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No