PTX-022 (sirolimus) 3.9% topical gel for angiokeratomas.
Official title: 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)
Run by Palvella Therapeutics, Inc. · NCT07552077 · Data updated 2026-11-12
This trial will test whether PTX-022, a 3.9% sirolimus topical gel, is safe and helps people aged 6 and older who have angiokeratomas.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Palvella Therapeutics, Inc. Industry-sponsored |
| Locations | 4 sites (Sherman Oaks, California and 3 other locations) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | August 2027 |
| Study ends | September 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07552077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 6 years or older with a confirmed diagnosis of angiokeratomas who can follow study procedures and give informed consent (or have a guardian consent) are the intended candidates.
✕Probably not a fit
Patients with a known allergy to sirolimus, significant concurrent medical conditions, or lesions that are deep/subcutaneous and unlikely to respond to topical therapy may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, baseline-controlled interventional trial tests a 3.9% sirolimus topical gel (PTX-022) applied to angiokeratoma lesions. Participants aged 6 years and older with diagnosed angiokeratomas will apply the gel according to the protocol and attend scheduled in-person visits at one of three U.S. sites for monitoring. Outcomes compare lesion appearance and symptoms to each participant's baseline while tracking adverse events to characterize safety. The trial excludes patients with known sirolimus allergy or significant concurrent conditions that could affect participation or safety.
Why it matters
Potential benefit: If successful, the gel could shrink or fade angiokeratomas and reduce symptoms such as bleeding or irritation with a topical, noninvasive option.
How similar studies have gone: Topical sirolimus has shown benefit in other vascular and cutaneous lesions, but its use specifically for angiokeratomas is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Cleaver Medical Group
Dawsonville, Georgia, United States Recruiting -
Epiphany Dermatology
Southlake, Texas, United States Recruiting -
Unified Health
Sherman Oaks, California, United States Not yet recruiting -
Vividia Dermatology
Las Vegas, Nevada, United States Not yet recruiting
Study contacts
- Study coordinator: Emily Cook
- Email: emily.cook@palvellatx.com
- Phone: 267-738-6366
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.