An open, uncontrolled pharmacokinetic study with a new topical combination gel containing triiodothyroacetic acid (TRIAC) and dehydroepiandrosterone (DHEA) in subjects with skin atrophy due to topical treatment with glucocorticoids.
At the Baseline Visit (Day 1) and after completion of all evaluations, each subject who qualifies for entry will will receive a dose of 0.5 g IMP on the back of a hand affected with skin atrophy. PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
Roskilde University Hospital, Dept of Dermatology
Roskilde, Denmark
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
MS-based method for analysis of DHEA will be used.
Time frame: 0-72 hours
Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
MS-based method for analysis of TRIAC will be used.
Time frame: 0-72 hours
Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
MS-based method for analysis of DHEA-S will be used.
Time frame: 0-72 hours
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