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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PP405 0.05% Topical Gel | Active Comparator | 0.05% Topical Gel applied once daily |
|
| PP405 Topical Vehicle Gel | Placebo Comparator | Placebo Topical Gel applied once daily |
|
| PP405 0.05% Topical Gel - Open Label Extension | Other | 0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP405 0.05% Topical Gel | Drug | PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment-related adverse events | Collection of adverse events, treatment emergent adverse events and serious adverse events. | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE |
| Change in local dermal tolerability as assessed by subject and investigator | Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe) | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PP405 | To assess the concentration of PP405 in plasma | Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Weng | Pelage Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| Clinical Trials Research Institute |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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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.
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| PP405 Topical Vehicle Gel | Drug | PP405 Vehicle = placebo |
|
| Thousand Oaks |
| California |
| 91320 |
| United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| Stride Clinical Research LLC | Sugar Land | Texas | 77479 | United States |
| Jordan Valley Dermatology Center | South Jordan | Utah | 84095 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |