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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)

Phase II Interventional Angiokeratomas

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 →

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗