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)
Part of paid clinical trials in Sherman Oaks, California.
- Sponsor
- Palvella Therapeutics, Inc.
- Study ID
- NCT07552077
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Angiokeratomas
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PTX-022 — DRUGtopical administration of PTX-022
Study Details
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open label
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
Central Contacts
- Emily Cook267-738-6366
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Unified Health | Sherman Oaks | California | 91403 | Michael Lin, MD (PRINCIPAL_INVESTIGATOR) |
| Cleaver Medical Group | Dawsonville | Georgia | 30534 | Nathan Cleaver, MD (PRINCIPAL_INVESTIGATOR) |
| Vividia Dermatology | Las Vegas | Nevada | 89148 | Graham Lichtman, MD Graham Lichtman, MD (PRINCIPAL_INVESTIGATOR) |
| Epiphany Dermatology | Southlake | Texas | 76092 | Todd Plott, MD (PRINCIPAL_INVESTIGATOR) |