Clinical trial NCT04016025: A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers
Official title: Randomized Single-blind Study on the Adherence to Treatment With Topical Methylprednisolone Aceponate (Advantan®) in Different Vehicles (AD-HERE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adherence, Patient
Chronic Eczema
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single-blind
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent has been obtained.
2. 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).
3. Subjects (male or female) aged from 18 to 65 years.
4. In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.
5. 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).
6. Female subjects must not be breastfeeding.

Exclusion Criteria:

1. females who are pregnant or breast-feeding.
2. Systemic treatment with immunosuppressive drugs, retinoids or corticosteroids within 8 weeks prior to randomization.
3. Phototherapy (PUVA or UVB) on the hands within 4 weeks prior to randomization.
4. Topical applied treatment with immunomodulators (e.g. pimecrolimus or tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
5. 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.
6. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization.
7. Concurrent skin diseases on the hands and/or integument with acute flare and/or skin lesions within the last 8 weeks.
8. Current diagnosis of eczema on the integument except for the hands.
9. Current diagnosis of exfoliative dermatitis.
10. Current diagnosis of glaucoma or cataract.
11. Significant clinical infection on the hands which requires antibiotic treatment.
12. Known or suspected hypersensitivity to component(s) of the IMP.
13. Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
14. Former participation in this clinical trial.
15. Current participation in any other interventional clinical trial.
16. 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).
17. 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.

Primary outcomes:
measure: Adherence to treatment
timeFrame: 28 days
measure: Measurement 1
timeFrame: 28 days; visit 1 (day 1)
measure: Measurement 2
timeFrame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
measure: Individual amount of topical drug
timeFrame: 28 days
measure: Truly applicated daily dose
timeFrame: 28 days
Secondary outcomes:
measure: Change of Hand Eczema
timeFrame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
measure: Change of Hand Eczema
timeFrame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringia
Study officials:
affiliation: University hospital Jena
name: Peter Elsner, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.