NCT02152007

Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

Phase 1b Clinical Trial Using Topical Sirolimus for the Treatment of Pachyonychia Congenita

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: TransDerm, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pachyonychia Congenita

Interventions

Type	Name	Description
DRUG	1% sirolimus cream (TD201 1%)	1% sirolimus cream (TD201 1%)

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2014-06-02
• Last updated: 2016-10-07
• Results posted: 2016-10-07

Locations

1 site across 1 country: United States