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Adherence, PatientPhase 4AD-HERENCT04016025

A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers

A Phase 4 study testing Adherence to topical standard therapy assessed in people with Adherence, Patient and Chronic Eczema, run by Jena University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem Handekzem in Abhängigkeit von der Galenik Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Adherence, Patient, Chronic Eczema
What is being tested?
Adherence to topical standard therapy assessed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteGermany
Study dates
2 Dec 2020to 14 Apr 2022
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent has been obtained.
  • Clinical diagnosis of chronic mild-to-moderate hand dermatitis with or without atopic etiology or background (according to IGA: at least mild at Visit 1).
  • Subjects (male or female) aged from 18 to 65 years.
  • In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.
  • Female subjects must be of either:
  • non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or,
  • childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy Female subjects of childbearing potential must be willing to use highly effective methods of contraception to avoid causing pregnancy from enrolment and until the last visit (V3).
  • Female subjects must not be breastfeeding.

Who cannot join

  • females who are pregnant or breast-feeding.
  • Systemic treatment with immunosuppressive drugs, retinoids or corticosteroids within 8 weeks prior to randomization.
  • Phototherapy (PUVA or UVB) on the hands within 4 weeks prior to randomization.
  • Topical applied treatment with immunomodulators (e.g. pimecrolimus or tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
  • Use of other treatment on the hands during the clinical trial except for the use of investigational medicinal product (IMP) and emollient provided by sponsor during the clinical trial.
  • Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization.
Show all 17Show fewer
  • Concurrent skin diseases on the hands and/or integument with acute flare and/or skin lesions within the last 8 weeks.
  • Current diagnosis of eczema on the integument except for the hands.
  • Current diagnosis of exfoliative dermatitis.
  • Current diagnosis of glaucoma or cataract.
  • Significant clinical infection on the hands which requires antibiotic treatment.
  • Known or suspected hypersensitivity to component(s) of the IMP.
  • Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
  • Former participation in this clinical trial.
  • Current participation in any other interventional clinical trial.
  • Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
  • Close affiliation with the investigator or other employees of the trial site (e.g. a close relative) or persons working at LEO Pharma A/S or Bayer Consumer Care AG or subject is an employee of sponsor.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Jena University Hospital

    Jena, Thuringia, 07743

Other trials in Germany

About this study

Official title: Randomized Single-blind Study on the Adherence to Treatment With Topical Methylprednisolone Aceponate (Advantan®) in Different Vehicles (AD-HERE)

Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem Handekzem in Abhängigkeit von der Galenik

Read the detailed description

Prospective, randomized, parallel grouped, single-blinded (investigator), monocentric objective assessment of the adherence to the treatment with topical methylprednisolone aceponate (Advantan®) depending on the type of vehicle in patients with hand eczema treated according to the current Guideline.

Being tested
Adherence to topical standard therapy assessed
Medical subject headings
Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence to topical standard therapy assessedBehavioural

    Adherence defined as percentage of patients applying at least aimed daily dose

Study groups in NCT04016025
Study groupRoleWhat they receive
creamActive comparatorTreatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)
Receives: Behavioral: Adherence to topical standard therapy assessed
fatty ointmentActive comparatorTreatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)
Receives: Behavioral: Adherence to topical standard therapy assessed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to treatment

    Adherence defined as percentage of patients applying at least aimed daily dose Adherence will be assumed, if

    • truly applicated daily dose is at least 75% of prescribed daily dose and
    • the individual mean number of applications per day is at least 0.85

    Measured: 28 days

  2. Measurement 1

    Hand surface [cm²]

    Measured: 28 days; visit 1 (day 1)

  3. Measurement 2

    Weight of topical drug container [mg]

    Measured: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)

  4. Individual amount of topical drug

    • weight of topical drug container [mg] by hand surface [cm²] will be combined to individual amount of topical drug which will as well be the prescribed daily dose

    Measured: 28 days

  5. Truly applicated daily dose

    • individual amount of topical drug used [mg/cm²] by individual mean number of applications

    Measured: 28 days

Secondary outcomes (2)

  1. Change of Hand Eczema

    Hand Eczema Severity Index (HECSI) Score: 0-360 Points (Total HECSI score = Sum (E, I, V, F, S, O) X Ex (Fingertips) + Sum (E, I, V, F, S, O) X Ex (Fingers except tips) + Sum (E, I, V, F, S, O) X Ex (Palm of hands) + Sum (E, I, V, F, S, O) X Ex (Back of hands) + Sum (E, I, V, F, S, O) X Ex (Wrists))

    Measured: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)

  2. Change of Hand Eczema

    Investigator's global Assessment (IGA) Score: 0-4 Points (0=Clear, 1=Almost clear, 2=Mild, 3=Moderate, 4=Severe)

    Measured: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study start2 Dec 2020
  3. Primary completion11 Mar 2022
  4. Study completion14 Apr 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized single-blind
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016025
Sponsor's protocol ID
ZKSJ0119_AD-HERE
Other IDs
2019-001324-35, 2019
Acronym
AD-HERE
Status last verified
May 2022
First submitted
28 Jun 2019
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diepgen TL, Andersen KE, Chosidow O, Coenraads PJ, Elsner P, English J, Fartasch M, Gimenez-Arnau A, Nixon R, Sasseville D, Agner T. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1-22. doi: 10.1111/ddg.12510_1.

    PubMed 25763418

  • Torrelo A. Methylprednisolone aceponate for atopic dermatitis. Int J Dermatol. 2017 Jun;56(6):691-697. doi: 10.1111/ijd.13485. Epub 2017 Mar 4.

    PubMed 28258632

  • Schliemann S, Petri M, Elsner P. How much skin protection cream is actually applied in the workplace? Determination of dose per skin surface area in nurses. Contact Dermatitis. 2012 Oct;67(4):229-33. doi: 10.1111/j.1600-0536.2012.02119.x. Epub 2012 Jun 18.

    PubMed 22709142

  • Lee JY, Choi JW, Kim H. Determination of hand surface area by sex and body shape using alginate. J Physiol Anthropol. 2007 Jun;26(4):475-83. doi: 10.2114/jpa2.26.475.

    PubMed 17704626

  • Gray R, Wykes T, Gournay K. From compliance to concordance: a review of the literature on interventions to enhance compliance with antipsychotic medication. J Psychiatr Ment Health Nurs. 2002 Jun;9(3):277-84. doi: 10.1046/j.1365-2850.2002.00474.x.

    PubMed 12060371

  • Ofenloch RF, Weisshaar E, Dumke AK, Molin S, Diepgen TL, Apfelbacher C. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ): validation of the German version of a new disease-specific measure of quality of life for patients with hand eczema. Br J Dermatol. 2014 Aug;171(2):304-12. doi: 10.1111/bjd.12819. Epub 2014 Jun 18.

    PubMed 24397866

  • Agner T, Jungersted JM, Coenraads PJ, Diepgen T. Comparison of four methods for assessment of severity of hand eczema. Contact Dermatitis. 2013 Aug;69(2):107-11. doi: 10.1111/cod.12039.

    PubMed 23869730

  • Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Hollo P, Cambazard F, Lahfa M, Elsner P, Nyberg F, Svensson A, Brown TC, Harsch M, Maares J. Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial. Br J Dermatol. 2008 Apr;158(4):808-17. doi: 10.1111/j.1365-2133.2008.08487.x. Epub 2008 Feb 21.

    PubMed 18294310

  • Reich A, Chatzigeorkidis E, Zeidler C, Osada N, Furue M, Takamori K, Ebata T, Augustin M, Szepietowski JC, Stander S. Tailoring the Cut-off Values of the Visual Analogue Scale and Numeric Rating Scale in Itch Assessment. Acta Derm Venereol. 2017 Jun 9;97(6):759-760. doi: 10.2340/00015555-2642. No abstract available.

    PubMed 28224165

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adherence to topical standard therapy assessed in people with Adherence, Patient and Chronic Eczema, run by Jena University Hospital at 1 site in Germany.

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 17 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 10 May 2022. 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 Germany. 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?

Adherence to treatment (time frame: 28 days). The study lists 5 primary outcomes in all. 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 NCT04016025, which also lists 9 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 10 May 2022.

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