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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pachyonychia Congenita

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type ACTIVE_COMPARATOR

QTORIN 3.9% rapamycin anhydrous gel

Intervention Type DRUG

QTORIN 3.9% rapamycin anhydrous gel

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Matching vehicle (QTORIN anyhydrous gel)

Interventions

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QTORIN 3.9% rapamycin anhydrous gel

Intervention Type DRUG

Vehicle

Matching vehicle (QTORIN anyhydrous gel)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No