Skin Atrophy Clinical Trial
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
Verified date | December 2018 |
Source | Trophea Development AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Written informed consent has been obtained prior to initiating any study specific procedures 2. Men and women of at least 18 years old 3. Subjects with hand eczema and confirmed skin atrophy on the back of a hand caused by treatment with topical glucocorticoids for at least 6 months 4. Atrophic skin area of approximately 100 cm2 (back of a hand) 5. Females of childbearing potential must have a negative urine pregnancy test result upon entry into the study 6. Females of child-bearing potential may participate only if using reliable means of contraception Exclusion Criteria: 1. Skin atrophy with open ulcer(s) involved 2. Participation in any other study involving investigational drug(s) within 30 days prior to study entry 3. Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues, DHEA, and testosterone within 3 weeks before entry into the study 4. Known thyroid disease of any type 5. Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other androgen excess syndromes 6. Subjects who have previously participated in this study |
Country | Name | City | State |
---|---|---|---|
Denmark | Roskilde University Hospital, Dept of Dermatology | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Trophea Development AB | Uppsala University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |