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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
View on ClinicalTrials.gov →
NCT07552077
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 siteUnified Health
Sherman Oaks, California, 91403
Georgia
1 siteCleaver Medical Group
Dawsonville, Georgia, 30534
Nevada
1 siteTexas
1 siteBrowse More Trials
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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Actively Recruiting
PhasePhase 2
SponsorPalvella Therapeutics, Inc.
Started2026-04
Est. completion2027-08
Eligibility
Age6 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT07552077