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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)

RECRUITINGPhase 2Sponsored by Palvella Therapeutics, Inc.
Actively Recruiting
PhasePhase 2
SponsorPalvella Therapeutics, Inc.
Started2026-04
Est. completion2027-08
Eligibility
Age6 Years+
Healthy vol.Accepted
Locations4 sites

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

Age: 6 Years+Healthy volunteers accepted
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

Conditions2

AngiokeratomasCancer

Interventions1

Locations4 sites

California

1 site
Unified Health
Sherman Oaks, California, 91403
Jamie Goodnight(833) 525-CURA (2872)jgoodnight@curaclinicalresearch.com

Georgia

1 site
Cleaver Medical Group
Dawsonville, Georgia, 30534
Dana Anderson770.800.3455danderson@cleavermedicalgroup.com

Nevada

1 site
Vividia Dermatology
Las Vegas, Nevada, 89148
Graham Lichtman, MDgraham.litchman@gmail.com

Texas

1 site
Epiphany Dermatology
Southlake, Texas, 76092
Moraima Avalos(214) 884 - 7558chintan@stryderesearch.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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