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Phase III

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 (VAPAUS)

  • Study HIC#:2000031568
  • Last Updated:11/11/2022

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.

  • Age18 years and older
  • GenderBoth
  • Start Date01/14/2022
  • End Date06/30/2023

Trial Purpose and Description

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.

Eligibility Criteria

Key Inclusion Criteria:

  • Adult patients, 18 years or older (16 years or older in the UK)
  • Diagnosed with Pachyonychia Congenita (PC), genetically confirmed

Key Exclusion Criteria:

  • Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications.
  • Any significant concurrent condition (including conditions involving or inferior to the ankle) that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study.
  • Participation in any other interventional clinical research trial within 30 days prior to the screening visit or during the patient's participation in this study

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