NCT07552077PHASE2Recruiting
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.
Start Date
4/1/2026
Completion Date
9/1/2027
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 Criteria
Age Range: 6 years to No maximum
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-required activities
Interventions
DRUG
PTX-022
Conditions
Angiokeratomas
Locations
Unified Health
Sherman Oaks, California 91403
United States
Cleaver Medical Group
Dawsonville, Georgia 30534
United States
Vividia Dermatology
Las Vegas, Nevada 89148
United States
Epiphany Dermatology
Southlake, Texas 76092
United States