A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers

Study Overview
=================
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.

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

Conditions
-----------------
Adherence, Patient, Chronic Eczema

Intervention / Treatment
-----------------
* Behavioral: Adherence to topical standard therapy assessed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized single-blind
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cream<br>Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm) | Behavioral: Adherence to topical standard therapy assessed<br>* Adherence defined as percentage of patients applying at least aimed daily dose<br>|
| Active Comparator: fatty ointment<br>Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm) | Behavioral: Adherence to topical standard therapy assessed<br>* Adherence defined as percentage of patients applying at least aimed daily dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28) | 
| Change of Hand Eczema | Investigator's global Assessment (IGA) Score: 0-4 Points (0=Clear, 1=Almost clear, 2=Mild, 3=Moderate, 4=Severe) | 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28) |