Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
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|ClinicalTrials.gov Identifier: NCT03783988|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Atrophy||Combination Product: DHEA and TRIAC||Phase 1|
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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a pharmacokinetic study to study the systemic levels of DHEA, DHEAs and TRIAC, before and after application of a new topical combination gel containing DHEA and TRIAC. MS-based validated methods will be used.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Open uncontrolled pharmacokinetic study
Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
Combination Product: DHEA and TRIAC
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
- Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours. [ Time Frame: 0-72 hours ]MS-based method for analysis of DHEA will be used.
- Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours. [ Time Frame: 0-72 hours ]MS-based method for analysis of TRIAC will be used.
- Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours. [ Time Frame: 0-72 hours ]MS-based method for analysis of DHEA-S will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783988
|Roskilde University Hospital, Dept of Dermatology||Not yet recruiting|
|Roskilde, Denmark, 4000|
|Contact: Gregor Jemec, MD, Prof.|