Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids

Study Overview
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Brief Summary
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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.

Detailed Description
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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 PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Official Title
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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

Conditions
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Skin Atrophy

Intervention / Treatment
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* Combination Product: DHEA and TRIAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open uncontrolled pharmacokinetic study<br>Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA | Combination Product: DHEA and TRIAC<br>* The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |