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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03783988

Enrollment

Registered

2018-12-21

Start date

2019-01-15

Completion date

2019-06-30

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Atrophy

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 PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Interventions

COMBINATION_PRODUCTDHEA and TRIAC

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 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.
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026