Atopic DermatitisPhase 4NCT04114097
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
A Phase 4 study testing Protopic, tacrolimus ointment 0.1% in people with Atopic Dermatitis and Atopic Eczema, run by Jacob Thyssen at 1 site in Denmark.
Trial summary
The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Eczema
- What is being tested?
- Protopic, tacrolimus ointment 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Aug 2019to 15 Mar 2021
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- AD according to the Hanifin and Rajka Criteria24
- AD for at least 3 years
- BMI ≤ 30 kg/m2
- Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
- Normal haemoglobin (men: 8.3-10.5 mmol/L and women 7.3-9.5 mmol/L. A 5% deviation will be allowed if the patient besides this is healthy)
- Informed consent
- In general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Further patients should not suffer from kidney or liver disease/insufficiency. See the SPC for Protopic and Betnovate.)
Who cannot join
- Diagnosed diabetes mellitus
- Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
- Pregnancy (a urine test will be done at every visit and birth control is required, see below*)
- Breast feeding
- Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
- Daily smoker, alcoholic, or drug abuser
- Hypersensitivity to Protopic or Betnovate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology and Allergy
Hellerup, Capital Region, 2900
About this study
The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Being tested
- Betnovate, betamethasone dipropionate ointment 0.1% and placebo, Protopic, tacrolimus ointment 0.1%
- Keywords
- topical corticosteroids, topical calcineurin inhibitors
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betnovate, betamethasone dipropionate ointment 0.1% and placeboDrug
Explore the systemic effects of Betnovate
Protopic, tacrolimus ointment 0.1%Drug
Compare the systemic effects of Betnovate to Protopic
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone-17-valerat + placebo ointment | Experimental | Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo Receives: Drug: Betnovate, betamethasone dipropionate ointment 0.1% and placebo |
| Tacrolimus ointment | Active comparator | Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%) Receives: Drug: Protopic, tacrolimus ointment 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole-body insulin sensitivity
Change in whole-body insulin sensitivity during treatment with topical corticosteroid use compared to the control group treated with topical calcineurin inhibitors. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose and glycerol tracer and indirect calorimetry (rate of disappearance (Rd)).
Measured: Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start22 Aug 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, two-arm, active comparator, double-dummy, double-blinded trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob Thyssen
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor-investigator, Jacob Thyssen, University Hospital, Gentofte, Copenhagen
- Investigators
- Jacob P Thyssen, Professor, MD, DMSc, Principal investigator, Department of Dermatology and Allergy, Gentofte Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114097
- Sponsor's protocol ID
- H-18064175
- Status last verified
- Apr 2021
- First submitted
- 1 Oct 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amiri D, Hellmann PH, Thyssen JP, Skov L, Kolko M, Gether L. Intraocular Pressure During Short-Term Topical or Systemic Corticosteroid Treatment: Analysis of 3 Randomized Clinical Trials. JAMA Dermatol. 2026 May 13:e261183. doi: 10.1001/jamadermatol.2026.1183. Online ahead of print.
PubMed 42126851Gether L, Storgaard H, Kezic S, Jakasa I, Hartmann B, Skov-Jeppesen K, Holst JJ, Pedersen AJ, Forman J, van Hall G, Sorensen OE, Skov L, Ropke MA, Knop FK, Thyssen JP. Effects of topical corticosteroid versus tacrolimus on insulin sensitivity and bone homeostasis in adults with atopic dermatitis-A randomized controlled study. Allergy. 2023 Jul;78(7):1964-1979. doi: 10.1111/all.15690. Epub 2023 Mar 21.
PubMed 36824052
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
- ClinicalTrials.gov ID
- NCT04114097
- Acronym / sponsor ID
- H-18064175
- Conditions
- Atopic Dermatitis, Atopic Eczema
- Keywords
- topical corticosteroids, topical calcineurin inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jacob ThyssenUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 3 Oct 2019 (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.
The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised, two-arm, active comparator, double-dummy, double-blinded trial
| Arm | Type | Receives |
|---|---|---|
| Betamethasone-17-valerat + placebo ointment | Experimental | Drug: Betnovate, betamethasone dipropionate ointment 0.1% and placeboAtopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid ("Betnovate", betamethasone dipropionate ointment 0.1%) and placebo |
| Tacrolimus ointment | Active comparator | Drug: Protopic, tacrolimus ointment 0.1%Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years
- AD according to the Hanifin and Rajka Criteria24
- AD for at least 3 years
- BMI ≤ 30 kg/m2
- Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
Key exclusion criteria (7 listed)
- Diagnosed diabetes mellitus
- Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
- Pregnancy (a urine test will be done at every visit and birth control is required, see below*)
- Breast feeding
- Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
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 |
|---|---|---|
| Betnovate, betamethasone dipropionate ointment 0.1% and placeboExplore the systemic effects of Betnovate | Drug | Betamethasone-17-valerat + placebo ointment |
| Protopic, tacrolimus ointment 0.1%Compare the systemic effects of Betnovate to Protopic | Drug | Tacrolimus ointment |
Primary outcome
Change in whole-body insulin sensitivity
Time frame: Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly
Change in whole-body insulin sensitivity during treatment with topical corticosteroid use compared to the control group treated with topical calcineurin inhibitors. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose and glycerol tracer and indirect calorimetry (rate of disappearance (Rd)).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 42126851Amiri D, Hellmann PH, Thyssen JP, Skov L, Kolko M, Gether L. Intraocular Pressure During Short-Term Topical or Systemic Corticosteroid Treatment: Analysis of 3 Randomized Clinical Trials. JAMA Dermatol. 2026 May 13:e261183. doi: 10.1001/jamadermatol.2026.1183. Online ahead of print.
- Derived from this study: PubMed 36824052Gether L, Storgaard H, Kezic S, Jakasa I, Hartmann B, Skov-Jeppesen K, Holst JJ, Pedersen AJ, Forman J, van Hall G, Sorensen OE, Skov L, Ropke MA, Knop FK, Thyssen JP. Effects of topical corticosteroid versus tacrolimus on insulin sensitivity and bone homeostasis in adults with atopic dermatitis-A randomized controlled study. Allergy. 2023 Jul;78(7):1964-1979. doi: 10.1111/all.15690. Epub 2023 Mar 21.
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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.
Jacob P Thyssen, Professor, MD, DMSc principal investigator
Department of Dermatology and Allergy, Gentofte Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Protopic, tacrolimus ointment 0.1% in people with Atopic Dermatitis and Atopic Eczema, run by Jacob Thyssen 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 28 Apr 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 whole-body insulin sensitivity (time frame: Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114097, which also lists 2 linked publications.
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 28 Apr 2021.