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

NCT ID: NCT03783988

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-06-30

Brief Summary

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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

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Conditions

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Skin Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open uncontrolled pharmacokinetic study

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

Group Type OTHER

DHEA and TRIAC

Intervention Type COMBINATION_PRODUCT

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

Interventions

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DHEA and TRIAC

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Trophea Development AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Roskilde University Hospital, Dept of Dermatology

Roskilde, , Denmark

Site Status

Countries

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Denmark

Facility Contacts

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Gregor Jemec, MD, Prof.

Role: primary

Other Identifiers

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TRO-SA01

Identifier Type: -

Identifier Source: org_study_id