Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Uppsala University | OTHER |
Not provided
Not provided
Not provided
Not provided
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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open uncontrolled pharmacokinetic study | Other | Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHEA and TRIAC | Combination Product | The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 0-72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roskilde University Hospital, Dept of Dermatology | Roskilde | 4000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| C010642 | 3,3',5-triiodothyroacetic acid |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |