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

Last updated: August 28, 2024
Sponsor: Palvella Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Vehicle

QTORIN 3.9% rapamycin anhydrous gel

Clinical Study ID

NCT05180708
PALV-05
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Adult patients, 18 years or older (16 years or older in the UK)

  • Diagnosed with Pachyonychia Congenita (PC), genetically confirmed

Exclusion

Key Exclusion Criteria:

  • Any history of allergy or hypersensitivity to sirolimus, or sirolimus-likemedications.

  • Any significant concurrent condition (including conditions involving or inferior tothe ankle) that could adversely affect the patient's participation and/or theassessment of the safety and efficacy in the study.

  • Participation in any other interventional clinical research trial within 30 daysprior to the screening visit or during the patient's participation in this study

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 3
Study Start date:
November 29, 2021
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Royal London Hospital

    London, Whitechapel E11FR
    United Kingdom

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Park Avenue Dermatology

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Oregon Health and Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • DermResearch, Inc.

    Austin, Texas 78759
    United States

    Site Not Available

  • University of Utah

    Murray, Utah 84107
    United States

    Site Not Available

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