Clinical trial NCT03783988: Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Skin Atrophy
Lead sponsor: Trophea Development AB
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University
First posted: 2018-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
timeFrame: 0-72 hours
measure: Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
timeFrame: 0-72 hours
measure: Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
timeFrame: 0-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde University Hospital, Dept of Dermatology
Study officials:
References: