The purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).
In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, Germany
Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
Time to complete or almost complete clearance according to IGA in both groups
Proportion of patients with complete or almost complete clearance according to the Patients Global Assessment (PGA) within 12 weeks and 24 weeks of active therapy
Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
Mean utilization of topical steroids within the follow-up period in both groups
Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
In patients with atopic dermatitis on the body: measured percentage of patients with at least 50% improvement in disease severity with the active therapy using the SCORAD.
Tolerability and safety in both study groups
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