Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03783988|
Recruitment Status : Unknown
Verified December 2018 by Trophea Development AB.
Recruitment status was: 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|
|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|
|Roskilde, Denmark, 4000|
|Contact: Gregor Jemec, MD, Prof.|