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

Trophea Development

Status and phase: Unknown; Phase 1

Conditions: Skin Atrophy

Treatments: Combination Product: DHEA and TRIAC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03783988

TRO-SA01

Details and patient eligibility

About

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.

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Open uncontrolled pharmacokinetic study

Other group

Description:

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

Treatment:

Combination Product: DHEA and TRIAC