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

Status and phase: Enrolling; Phase 2

Conditions: Angiokeratomas

Treatments: Drug: PTX-022

Study type: Interventional

Funder types: Industry

Identifiers

NCT07552077

PALV-12

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Open label

Experimental group

Treatment:

Drug: PTX-022