Clinical trial NCT06393452: Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Pelage Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects who were randomized to vehicle in Part 1 will be eligible to participate in the Open-label Extension in Part 2 of the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with treatment-related adverse events
timeFrame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
measure: Change in local dermal tolerability as assessed by subject and investigator
timeFrame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
Secondary outcomes:
measure: Pharmacokinetics of PP405
timeFrame: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Sugar Land
country: United States
facility: Stride Clinical Research LLC
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Pelage Pharmaceuticals
name: Christina Weng
role: STUDY_CHAIR
References: