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

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

• Status: Unknown
• Conditions: Skin Atrophy
• Intervention / Treatment: Combination product: DHEA and TRIAC

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PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.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

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Roskilde University Hospital, Dept of Dermatology
    • Contact: Gregor Jemec, MD, Prof.

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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	Combination product: DHEA and TRIAC; The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)

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.	MS-based method for analysis of DHEA will be used.	0-72 hours
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.	0-72 hours
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.	0-72 hours

Collaborators and Investigators

• Sponsor: Trophea Development AB
• Collaborators: Uppsala University

Study record dates

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: Pathological Conditions, Anatomical; Atrophy
• 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