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

Skin Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03783988
• Other study ID #: TRO-SA01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 15, 2019
• Est. completion date: June 2019

Study information

• Verified date: December 2018
• Source: Trophea Development AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Skin Atrophy

Intervention

Combination Product:
• DHEA and TRIAC
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)

Locations

Country	Name	City	State
Denmark	Roskilde University Hospital, Dept of Dermatology	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Trophea Development AB	Uppsala University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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