CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
PTX-022drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05050149
NCT05050149Phase 2Completed

A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

Palvella Therapeutics, Inc.·interventional·Posted Sep 20, 2021·Updated Jan 17, 2025

In Brief

A Phase 2 clinical trial evaluating PTX-022 for Microcystic Lymphatic Malformation. Completed, enrolled 12 participants across 7 sites.

Detailed Summary

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 20, 2021
Enrollment StartJan 13, 2022
Primary CompletionNov 15, 2022
Study CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.8 years ago

Interventions

PTX-022drug

Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations