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

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ClinicalTrials.gov Identifier: NCT03783988
Recruitment Status : Unknown
Verified December 2018 by Trophea Development AB.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Trophea Development AB

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Atrophy Combination Product: DHEA and TRIAC Phase 1

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Open uncontrolled pharmacokinetic study
Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
 Combination Product: DHEA and TRIAC
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)


Outcome Measures
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Primary Outcome Measures :
  1. Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours. [ Time Frame: 0-72 hours ]
    MS-based method for analysis of DHEA will be used.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783988


Locations
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Denmark
Roskilde University Hospital, Dept of Dermatology
Roskilde, Denmark, 4000
Contact: Gregor Jemec, MD, Prof.         
Sponsors and Collaborators
Trophea Development AB
Uppsala University
More Information
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Responsible Party: Trophea Development AB
ClinicalTrials.gov Identifier: NCT03783988    
Other Study ID Numbers: TRO-SA01
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical