- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03783988
Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
December 20, 2018 updated by: Trophea Development AB
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
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 Overview
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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Roskilde, Denmark, 4000
- Roskilde University Hospital, Dept of Dermatology
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Contact:
- Gregor Jemec, MD, Prof.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent has been obtained prior to initiating any study specific procedures
- Men and women of at least 18 years old
- 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
- Atrophic skin area of approximately 100 cm2 (back of a hand)
- Females of childbearing potential must have a negative urine pregnancy test result upon entry into the study
- Females of child-bearing potential may participate only if using reliable means of contraception
Exclusion Criteria:
- Skin atrophy with open ulcer(s) involved
- Participation in any other study involving investigational drug(s) within 30 days prior to study entry
- Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues, DHEA, and testosterone within 3 weeks before entry into the study
- Known thyroid disease of any type
- Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other androgen excess syndromes
- Subjects who have previously participated in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Open uncontrolled pharmacokinetic study
Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
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The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
Time Frame: 0-72 hours
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MS-based method for analysis of DHEA will be used.
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0-72 hours
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Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
Time Frame: 0-72 hours
|
MS-based method for analysis of TRIAC will be used.
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0-72 hours
|
Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
Time Frame: 0-72 hours
|
MS-based method for analysis of DHEA-S will be used.
|
0-72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 15, 2019
Primary Completion (ANTICIPATED)
June 1, 2019
Study Completion (ANTICIPATED)
June 1, 2019
Study Registration Dates
First Submitted
December 3, 2018
First Submitted That Met QC Criteria
December 20, 2018
First Posted (ACTUAL)
December 21, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 21, 2018
Last Update Submitted That Met QC Criteria
December 20, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRO-SA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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