A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers

NCT04016025 | Completed Phase 4 DMC

• 2 other identifiers: ZKSJ0119_AD-HERE2019-001324-35
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adherence, Patient; Chronic Eczema

Outcome Measures

Primary Outcomes (5)

• 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

  28 days

• Measurement 1

  Hand surface \[cm²\]

  28 days; visit 1 (day 1)

• Measurement 2

  Weight of topical drug container \[mg\]

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

• 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

  28 days

• Truly applicated daily dose

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

  28 days

Secondary Outcomes (2)

• Change of Hand Eczema

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

• Change of Hand Eczema

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

Study Arms (2)

cream

ACTIVE COMPARATOR

Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)

Behavioral: Adherence to topical standard therapy assessed

fatty ointment

ACTIVE COMPARATOR

Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)

Behavioral: Adherence to topical standard therapy assessed

Interventions

Adherence to topical standard therapy assessed BEHAVIORAL

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

cream; fatty ointment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jena University Hospital: lead
• Bayer: collaborator

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07743, Germany

Location

Related Publications (9)

• 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.

  PMID: 25763418 BACKGROUND

• 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.

  PMID: 28258632 BACKGROUND

• 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.

  PMID: 22709142 BACKGROUND

• 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.

  PMID: 17704626 BACKGROUND

• 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.

  PMID: 12060371 BACKGROUND

• 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.

  PMID: 24397866 BACKGROUND

• 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.

  PMID: 23869730 BACKGROUND

• 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.

  PMID: 18294310 BACKGROUND

• 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.

  PMID: 28224165 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Peter Elsner, Prof. Dr. med.

  University hospital Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator of the study will not know in which vehicle the enrolled patient will receive the standard therapeutical drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. P. Elsner, Head of Dermatology, Principal Investigator

Model Details: Randomized single-blind

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 11, 2019
• Study Start: December 2, 2020
• Primary Completion: March 11, 2022
• Study Completion: April 14, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)