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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)
RecruitingPhase 2
Who can join
Ages 6 and older · All sexes
Full eligibility criteria
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
About the study
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
What is being tested
- PTX-022 (drug)
Sponsor: Palvella Therapeutics, Inc. · Participants: 15 · Started: 2026-04
Contact the study team
- Emily Cook · Phone: 267-738-6366
Official record on ClinicalTrials.gov — NCT07552077
Locations in the U.S.
| California | Unified Health, Sherman Oaks (Not yet recruiting) |
| Georgia | Cleaver Medical Group, Dawsonville |
| Nevada | Vividia Dermatology, Las Vegas (Not yet recruiting) |
| Texas | Epiphany Dermatology, Southlake |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.