Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

Status Completed

Clinical Trial Summary

A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Pachyonychia Congenita

Clinical Trial Details

NCT number	NCT02152007
Study type	Interventional
Source	TransDerm, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	January 2014
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT05180708` - 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	Phase 3
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Recruiting	`NCT05956314` - Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC	Phase 1
Not yet recruiting	`NCT01382511` - Simvastatin Treatment of Pachyonychia Congenita	N/A
Recruiting	`NCT05435638` - Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases	Phase 1
Completed	`NCT00716014` - Study of TD101, a Small Interfering RNA (siRNA) Designed for Treatment of Pachyonychia Congenita	Phase 1
Recruiting	`NCT02321423` - International Pachyonychia Congenita Research Registry
Active, not recruiting	`NCT03920228` - Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita	Phase 2/Phase 3