Status:
UNKNOWN
Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
Lead Sponsor:
Trophea Development AB
Collaborating Sponsors:
Uppsala University
Conditions:
Skin Atrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- Written informed consent has been obtained prior to initiating any study specific procedures
- Men and women of at least 18 years old
- 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
- Atrophic skin area of approximately 100 cm2 (back of a hand)
- Females of childbearing potential must have a negative urine pregnancy test result upon entry into the study
- Females of child-bearing potential may participate only if using reliable means of contraception
Exclusion
- Skin atrophy with open ulcer(s) involved
- Participation in any other study involving investigational drug(s) within 30 days prior to study entry
- Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues, DHEA, and testosterone within 3 weeks before entry into the study
- Known thyroid disease of any type
- Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other androgen excess syndromes
- Subjects who have previously participated in this study
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03783988
Start Date
January 15 2019
End Date
June 1 2019
Last Update
December 21 2018
Active Locations (1)
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1
Roskilde University Hospital, Dept of Dermatology
Roskilde, Denmark, 4000