A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

Phase 3 Completed 87 enrolled Palvella Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluates the safety and efficacy of QTORIN 3.9% rapamycin anhydrous gel in the treatment of adults with Pachyonychia Congenita. This study includes a screening period, baseline period and 6-month treatment period.

Timeline

Start: 2021-11-29
Primary completion: 2023-06-30
Completion: 2023-06-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Sirolimus	Small molecule	3.9 %	—

A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

Summary

Timeline

Drugs

Indications