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)
Purpose
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
Condition
- Angiokeratomas
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open label |
|
Recruiting Locations
Cleaver Medical Group
Dawsonville, Georgia 30534
Dawsonville, Georgia 30534
Epiphany Dermatology
Southlake, Texas 76092
Southlake, Texas 76092
More Details
- NCT ID
- NCT07552077
- Status
- Recruiting
- Sponsor
- Palvella Therapeutics, Inc.