Skin AtrophyPhase 1NCT03783988
Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids
A Phase 1 study testing DHEA and TRIAC in people with Skin Atrophy, run by Trophea Development AB at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Atrophy
- What is being tested?
- DHEA and TRIAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2019to Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Roskilde University Hospital, Dept of Dermatology
Roskilde, 4000
Gregor Jemec, MD, Prof.
About this study
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
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.
Read the 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.
- Conditions
- Skin Atrophy
- Being tested
- DHEA and TRIAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEA and TRIACCombination product
The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
| Study group | Role | What they receive |
|---|---|---|
| Open uncontrolled pharmacokinetic study | Other | Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA Receives: Combination Product: DHEA and TRIAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start15 Jan 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trophea Development AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783988
- Sponsor's protocol ID
- TRO-SA01
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03783988
- Acronym / sponsor ID
- TRO-SA01
- Conditions
- Skin Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Trophea Development ABIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open uncontrolled pharmacokinetic study | Other | Combination Product: DHEA and TRIACSingle armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEA and TRIACThe new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC) | Combination product | Open uncontrolled pharmacokinetic study |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHEA and TRIAC in people with Skin Atrophy, run by Trophea Development AB at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours. (time frame: 0-72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.