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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03783988
Other study ID # TRO-SA01
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.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

Study Design


Related Conditions & MeSH terms


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