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)

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

Recruiting

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Key information

Conditions

Angiokeratomas Angiokeratoma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unified Health, Sherman Oaks, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTX-022

Drug

topical administration of PTX-022

Primary outcomes

Incidence of Treatment-Emergent Adverse Events

Time frame: 3 months
Overall Angiokeratoma Investigator Global Assessment (AK-IGA)

Time frame: 3 months
Overall Patient Global Impression of Change (PGI-C)

Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Cook

CONTACT

[email protected]

267-738-6366

Sponsors and collaborators

Lead sponsor

Palvella Therapeutics, Inc.

Industry

Registry information

Acronym: LOTU

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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