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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

NCT05180708 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-08-29

No results posted yet for this 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.

Conditions

  • Pachyonychia Congenita

Interventions

DRUG

QTORIN 3.9% rapamycin anhydrous gel

QTORIN 3.9% rapamycin anhydrous gel

DRUG

Vehicle

Matching vehicle (QTORIN anyhydrous gel)

Sponsors & Collaborators

  • Palvella Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amy Paller, MD · Northwestern University

  • Joyce Teng, MD · Stanford University

  • David Hansen, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180708 on ClinicalTrials.gov