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)
| NCT ID | NCT07552077 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Palvella Therapeutics, Inc. |
| Condition | Angiokeratomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2026-04 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07552077 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Angiokeratomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07552077 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07552077 currently recruiting?
Yes, NCT07552077 is actively recruiting participants. Contact the research team at emily.cook@palvellatx.com for enrollment information.
Where is the NCT07552077 trial being conducted?
This trial is being conducted at Sherman Oaks, United States, Dawsonville, United States, Las Vegas, United States, Southlake, United States.
Who is sponsoring the NCT07552077 clinical trial?
NCT07552077 is sponsored by Palvella Therapeutics, Inc.. The trial plans to enroll 15 participants.