Recruiting NCT07552077
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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PTX-022.
- Who it may be relevant to
- Registry conditions: Angiokeratomas. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
Interventions
- Drug PTX-022
topical administration of PTX-022
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Unified Health — Sherman Oaks
- Cleaver Medical Group — Dawsonville
- Vividia Dermatology — Las Vegas
- Epiphany Dermatology — Southlake
Identifiers
NCT: NCT07552077 · PALV-12