Trial | NCT03783988  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    10
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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
Study Started
Jan 15
2019
Anticipated
Primary Completion
Jun 30
2019
Anticipated
Study Completion
Jun 30
2019
Anticipated
Last Update
Dec 21
2018

Combination Product DHEA and TRIAC [dehydroepiandrosterone, triiodothyroacetic acid]

The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)

Open uncontrolled pharmacokinetic study Other

Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA

Criteria 

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
No Results Posted