Atopic Dermatitis Clinical Trial
— TocyDDOfficial title:
Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | March 2013 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 Atopiescore1 and/or - positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or - elevated serum IgE - 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 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 <1% per year (eg, implants, depot preparations, oral contraceptives, IUD). - vasectomy of the partner. - Women within reproductive age, who do not meet all of the following criteria throughout the whole study or - in case of early study termination - up to 5 weeks after active therapy: - The patient understands the teratogenic risk associated with taking the study medication. - The patient understands the need for strict monthly monitoring, the need for a reliable, continuous contraception and the need for regular pregnancy tests throughout the study and - in case of early study termination - up to 5 weeks of active therapy. - The patient is able to adequately and reliably apply methods of contraception. - The patient is informed about the possible consequences of pregnancy and knows that she must immediately contact her physician in case of suspected pregnancy. - The patient gives informed consent about knowing the potential risks and necessary measures to avoid pregnancy. - Blood and/or plasma donation during the whole study period. In case of early study termination blood and plasma donation is not allowed until 1 month after the end of active study treatment - UV-therapy within past 3 months - Concurrent photo-and / or photochemotherapy - Known Hypersensitivity / Intolerance against ciclosporin, alitretinoin or any other ingredients of Immunosporin® or Toctino® - Known Allergy against peanuts or soya - Known Hereditary fructose intolerance - Acute and/or uncontrolled chronic infectious disease - Known Congenital or acquired immune deficiency - Malignant tumor (past or present) - Uncontrolled arterial hypertension (RR systolic = 160 mm Hg and/or RR diastolic= 90 mm Hg despite anti-hypertensive treatment) - Renal insufficiency (Serum creatinine above normal range) - Liver insufficiency (CHILD = Stadium B) - Not sufficiently controlled hyperlipidemia (LDL/HDL ratio > 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Sachsen |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups. | No | ||
Secondary | Time to complete or almost complete clearance according to IGA in both groups | No | ||
Secondary | 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 | No | ||
Secondary | Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups | No | ||
Secondary | Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups | No | ||
Secondary | Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D) | No | ||
Secondary | Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups | No | ||
Secondary | Mean utilization of topical steroids within the follow-up period in both groups | No | ||
Secondary | Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale) | No | ||
Secondary | Proportion of patients with relapse (= 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance | No | ||
Secondary | 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. | No | ||
Secondary | Tolerability and safety in both study groups | No |
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