Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Pelage Pharmaceuticals, Inc.78 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Androgenetic Alopecia

Interventions

PP405 0.05% Topical GelDRUG

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

Topical Vehicle GelDRUG

Vehicle = placebo topical gel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Minnesota Clinical Study Center

Outcomes

Primary Outcomes

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

Time frame: Baseline to Day 84 of the randomized portion of the study

Percentage of Subjects With Adverse Events

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

New Brighton, Minnesota, United States

DermResearch

Austin, Texas, United States

Stride Clinical Research LLC

Sugar Land, Texas, United States

Jordan Valley Dermatology Center

South Jordan, Utah, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

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

Secondary Outcomes

Pharmacokinetics of PP405

To assess the concentration of PP405 in plasma at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28

Time frame: Baseline to Day 28 of the randomized portion of the study

Pharmacokinetics of PP405

To assess the concentration of PP405 in plasma at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84 of the open label extension

Time frame: Baseline to Day 84 of the open label extension portion of the study