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

Primary Purpose

Skin Atrophy

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
DHEA and TRIAC
Sponsored by
Trophea Development AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roskilde University Hospital, Dept of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open uncontrolled pharmacokinetic study

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2018
Last Updated
December 20, 2018
Sponsor
Trophea Development AB
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT03783988
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trophea Development AB
Collaborators
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open uncontrolled pharmacokinetic study
Arm Type
Other
Arm Description
Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
Intervention Type
Combination Product
Intervention Name(s)
DHEA and TRIAC
Intervention Description
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
Primary Outcome Measure Information:
Title
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
Description
MS-based method for analysis of DHEA will be used.
Time Frame
0-72 hours
Title
Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
Description
MS-based method for analysis of TRIAC will be used.
Time Frame
0-72 hours
Title
Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
Description
MS-based method for analysis of DHEA-S will be used.
Time Frame
0-72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Roskilde University Hospital, Dept of Dermatology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor Jemec, MD, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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