CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
1% sirolimus cream (TD201 1%)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02152007
NCT02152007Phase 1Completed
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Phase 1b Clinical Trial Using Topical Sirolimus for the Treatment of Pachyonychia Congenita

TransDerm, Inc.·interventional·Posted Jun 2, 2014·Updated Oct 7, 2016

In Brief

A Phase 1 clinical trial evaluating 1% sirolimus cream (TD201 1%) for Pachyonychia Congenita. Completed, enrolled 15 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPachyonychia Congenita
CountriesUnited States
CollaboratorsPachyonychia Congenita Project

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2, 2014
Enrollment StartJan 1, 2014
Primary CompletionJul 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.1 years ago

Interventions

1% sirolimus cream (TD201 1%)drug

1% sirolimus cream (TD201 1%)