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)

NCT07552077 · tracked via the Priya Life Science USA tracker

Sponsor

Palvella Therapeutics, Inc.

Phase

Phase 2

Started

2026-04

Last updated

2026-04-27

Condition(s) studied

Angiokeratomas

Investigational drug(s) / intervention(s)

PTX-022

PTX-022: topical administration of PTX-022

Study 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

Sex

ALL

Min age

6 Years

Max age

—

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

Primary outcome measure(s)

Incidence of Treatment-Emergent Adverse Events — 3 months
Overall Angiokeratoma Investigator Global Assessment (AK-IGA) — 3 months
Overall Patient Global Impression of Change (PGI-C) — 3 months

Trial sites (4)

Facility	City	Region	Status
Unified Health	Sherman Oaks	California	Not Yet Recruiting
Cleaver Medical Group	Dawsonville	Georgia	Recruiting
Vividia Dermatology	Las Vegas	Nevada	Not Yet Recruiting
Epiphany Dermatology	Southlake	Texas	Recruiting

More Palvella Therapeutics, Inc. trials in the USA

A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita Recruiting

SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations Active, not recruiting

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07552077 on ClinicalTrials.gov ↗ ← All trials in the USA