drugset / Trial / NCT02152007

Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

NCT02152007

RandomizedSingle-groupQuadruple-blindTreatment

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

Timeline

Start
2014-01
Primary completion
2015-07
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 1 % Topical