A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)
Palvella Therapeutics, Inc.
Summary
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
Eligibility
- Age range
- 6+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be 6 years or older * Diagnosed with angiokeratoma * Able and willing to comply with all protocol-related activities * Willing and able to provide written informed consent Exclusion Criteria: * Any significant concurrent condition that could adversely affect participation * Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022 * Patients deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-r…
Interventions
- DrugPTX-022
topical administration of PTX-022
Locations (4)
- Unified HealthSherman Oaks, California
- Cleaver Medical GroupDawsonville, Georgia
- Vividia DermatologyLas Vegas, Nevada
- Epiphany DermatologySouthlake, Texas