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)

ConditionAngiokeratomas

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age6+

SponsorPalvella Therapeutics, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

PTX-022

Treatment groups

15 Participants

are divided into 1 treatment group

Sponsors and collaborators

Palvella Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov