Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem Handekzem in Abhängigkeit von der Galenik
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Adherence defined as percentage of patients applying at least aimed daily dose
Jena University Hospital
Jena, Thuringia, Germany
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
Time frame: 28 days
Measurement 1
Hand surface \[cm²\]
Time frame: 28 days; visit 1 (day 1)
Measurement 2
Weight of topical drug container \[mg\]
Time frame: 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
Time frame: 28 days
Truly applicated daily dose
\- individual amount of topical drug used \[mg/cm²\] by individual mean number of applications
Time frame: 28 days
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))
Time frame: 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)
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Time frame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)