Androgenetic Alopecia
Conditions
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.
Interventions
PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)
DRUGPP405 Topical Vehicle Gel
PP405 Vehicle = placebo
Sponsors
Pelage Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with treatment-related adverse events | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE | Collection of adverse events, treatment emergent adverse events and serious adverse events. |
| Change in local dermal tolerability as assessed by subject and investigator | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE | Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of PP405 | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE | To assess the concentration of PP405 in plasma |
Countries
United States
Outcome results
None listed