RecruitingPhase 2NCT07552077

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)


Sponsor

Palvella Therapeutics, Inc.

Enrollment

15 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

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Interventions

DRUGPTX-022

topical administration of PTX-022


Locations(4)

Unified Health

Sherman Oaks, California, United States

Cleaver Medical Group

Dawsonville, Georgia, United States

Vividia Dermatology

Las Vegas, Nevada, United States

Epiphany Dermatology

Southlake, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07552077