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)

Recruiting now · Phase 2

Conditions studied: Angiokeratomas

In brief

The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas

Key facts

Study ID

NCT07552077

Run by

Palvella Therapeutics, Inc.

People needed

15

Starts

2026-04-01

Expected to finish

2027-09-01

Last updated by the study team

2026-04-27

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleaver Medical Group — Dawsonville, Georgia, United States (enrolling)
• Epiphany Dermatology — Southlake, Texas, United States (enrolling)
• Unified Health — Sherman Oaks, California, United States
• Vividia Dermatology — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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