Chronic atopic hand dermatitis, not responding to potent topical corticosteroids.
Conditions
Interventions
Trade Name: Immunosporin 50 mg
Kapseln
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Medical Faculty, TU Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female Patients age 18 years and = 75 years - Body weight 50 to 100 kg - Chronic hand dermatitis (duration 6 months) - Atopic constitution according to - Erlanger Atopiescore and/or - positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or - elevated serum IgE (> 100 kU/L) - Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Participation in other clinical trial within past 4 weeks - Pregnancy/breastfeeding - Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination: - post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml), - postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy) - Regular and proper use of at least two methods of contraception, including at least one method of contraception with a failure rate 4 despite medical treatment) - Clinically significant thyroid hypofunction - Known Hypervitaminosis A - Concurrent supplementation of vitamin A or treatment with other retinoids - Concurrent tetracycline therapy - Concurrent therapy with St. John’s wort (“Johanniskraut“) - Known genetic diseases causing increased UV light sensitivity such as Xeroderma pigmentosum, Cockayne-syndrome, Bloom syndrome - Known Drug- and/or alcohol abuse - Known significant psychiatric morbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis. ;Primary end point(s): Primary study endpoint: Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups. ;Secondary Objective: - 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 | — |
Countries
Germany
Outcome results
None listed