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:12/22/2022
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
Contact Us
For more information about this study, including how to volunteer, contact:
Nicole Olszewski
- Phone Number: 1-203-785-5505
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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
