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

Phase 1

• Conditions: Skin Atrophy
• Interventions: Combination Product: DHEA and TRIAC

• Registration Number: NCT03783988
• Lead Sponsor: Trophea Development AB

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 treatment with glucocorticoids.

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-21
• Last Update Posted: 2018-12-21
• Study Start: 2019-01-15
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open uncontrolled pharmacokinetic study	DHEA and TRIAC	Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA

Primary Outcome Measures

Name	Time	Method
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.	0-72 hours	MS-based method for analysis of DHEA will be used.
Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.	0-72 hours	MS-based method for analysis of DHEA-S will be used.
Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.	0-72 hours	MS-based method for analysis of TRIAC will be used.

Trial Locations

Locations (1)

Roskilde University Hospital, Dept of Dermatology; 🇩🇰 Roskilde, Denmark