Phase 1Completed
Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)
Phase 1b Clinical Trial Using Topical Sirolimus for the Treatment of Pachyonychia Congenita
- Sponsor
- TransDerm, Inc. (Industry)
- Enrolment
- 15 enrolled
- Conditions
- Pachyonychia Congenita
- Interventions
- 1% sirolimus cream (TD201 1%)
- Ages
- children, adults, older adults
- Registry
- NCT02152007
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels
History
Results first posted
Last registry update
Study completion
Primary completion
Registered
Started