Actively Recruiting
Phase 2 Study of PTX-022 Sirolimus Topical Gel 3.9% to Treat Angiokeratomas
Led by Palvella Therapeutics, Inc. · Updated on 2026-04-27
15
Participants Needed
4
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an experimental drug called PTX-022, which is a topical gel containing 3.9% sirolimus, for treating angiokeratomas. This Phase 2 study aims to understand how well PTX-022 works and its safety profile in patients with this condition. The study is sponsored by Palvella Therapeutics, Inc. and includes participants aged 6 years and older. Participants in this open-label study will receive PTX-022 applied topically. The treatment period lasts for 3 months during which the drugs effects and safety will be monitored. There are no placebo or comparator groups all participants receive the experimental treatment. During the study, participants will be assessed for any treatment-related side effects and changes in their angiokeratomas using the Investigator Global Assessment and Patient Global Impression of Change scales. Researchers will collect data on adverse events and overall improvement at the 3-month mark. Participants are expected to follow all study procedures, including medication application and scheduled evaluations throughout the study duration.
CONDITIONS
Brief Title
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)
Research Team
E
Emily Cook
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