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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
1% sirolimus cream (TD201 1%)
Stanford University
Stanford, California, United States
Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels
The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.
Time frame: Two weeks and every 1-2 months for 24 weeks or within 2 weeks after the last dose of study drug
Weekly Assessments Recorded in the PC Quality of Life Index
Patient-reported weekly assessment in the PC Quality of Life Index
Time frame: Weekly for 39 weeks
Daily Assessments Recording in the PC Measurement Diary
Time frame: Weekly for 39 weeks
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