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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07552077

Acronym

LOTU

Enrollment

Registered

2026-04-27

Start date

2026-04-01

Completion date

2027-09-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiokeratomas

Keywords

angiokeratoma

Brief summary

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

Interventions

DRUGPTX-022

topical administration of PTX-022

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

CONTACTEmily Cook

emily.cook@palvellatx.com267-738-6366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026