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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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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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