A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pelage Pharmaceuticals, Inc.
- Enrollment
- 78
- Locations
- 8
- Primary Endpoint
- Percentage of Subjects With Adverse Events
Study Overview
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.
Detailed Description
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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-
- •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.
Arms & Interventions
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.
Intervention: Topical Vehicle Gel (Drug)
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.
Intervention: PP405 0.05% Topical Gel (Drug)
PP405 0.05% Topical Gel
PP405 0.05% Topical Gel applied once daily for 28 days.
Intervention: PP405 0.05% Topical Gel (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects With Adverse Events
Time Frame: Baseline to Day 84 of the randomized portion of the study
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
Percentage of Subjects With Adverse Events
Time Frame: Baseline to Day 84 of the open label extension portion of the study
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
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Time Frame: Post-dose at day 28 of the randomized portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Time Frame: Post-dose at day 84 of the open label extension portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change From Baseline in Blood Pressure
Time Frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)
Change From Baseline in Pulse Rate
Time Frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Temperature
Time Frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in temperature in the safety analysis population (day 84 minus baseline)
Change From Baseline in Respiratory Rate
Time Frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Weight
Time Frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in weight in the safety analysis population (day 84 minus baseline)
Change From Baseline in Blood Pressure
Time Frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Pulse Rate
Time Frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Temperature
Time Frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Respiratory Rate
Time Frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Weight
Time Frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
Time Frame: Baseline to day 28 of the randomized portion of the study
Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)
Change From Baseline in Electrocardiogram (ECG) Results
Time Frame: Baseline to day 28 of the randomized portion of the study
Electrocardiograms results were compared to baseline (day 28 minus baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
Time Frame: Baseline to day 84 of the open label extension portion of the study
Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)
Change From Baseline in Electrocardiograms (ECGs)
Time Frame: Baseline to day 84 of the open label extension portion of the study
Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)
Abnormal Laboratory Values
Time Frame: Day 28 post baseline in the randomized portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Abnormal Laboratory Values
Time Frame: Day 84 post baseline in the open label extension portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Secondary Outcomes
- 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)