NCT05180708

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pachyonychia Congenita

Interventions

Type	Name	Description
DRUG	QTORIN 3.9% rapamycin anhydrous gel	QTORIN 3.9% rapamycin anhydrous gel
DRUG	Vehicle	Matching vehicle (QTORIN anyhydrous gel)

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-01-06
• Last updated: 2024-08-29

Locations

8 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study