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| Sponsor: | ISDIN |
|---|---|
| Information provided by: | ISDIN |
| ClinicalTrials.gov Identifier: | NCT00578370 |
Purpose
Ciclosporin is a cyclic nonribosomal polypeptide of 11 amino acids produced by the fungi Tolypocladium inflatum and Cylindrocarpon lucidum. Ciclosporin is a highly efficient immunosuppressant drug widely used in post-allergenic organ transplant to reduce the activity of the subject's immune system and so the risk of organ rejection. Apart from transplant medicine, ciclosporin is also used in the treatment of autoimmune diseases like psoriasis and infrequently in rheumatoid arthritis and related diseases, although it is only used in severe cases.
Ciclosporin blocks the lymphocytes, especially the T-lymphocytes, in the G0- or G1-phase of the cell cycle. Moreover it inhibits the production and release of lymphokines including interleukin 2 or the T-cell growth factor.
Generally ciclosporin is taken orally (capsule or solution)or by injection in doses of 1.5 to 5.5 mg/kg/day. In the topical cutaneous emulsion presented here, ciclosporin is available at a concentration of 0.5 and 1.5%.
The purpose of this study is the demonstration of antipsoriatic efficacy and tolerability of topical cutaneous ciclosporin in subjects with psoriasis vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Ciclosporin 0.5% (Formulation 01B) Drug: Ciclosporin 1.5% (Formulation 02B) Drug: 0.1% betamethasone Drug: 0.005% calcipotriol Drug: Formulation 00B |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase I, Single-Center, Randomized, Vehicle-Controlled Study, Double-Blind for the Study Preparations and Observer-Blind for the Comparators to Determine the Antipsoriatic Efficacy and Tolerability of Topical Formulations With Ciclosporin in a Psoriasis Plaque Test |
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Ciclosporin 0.5% (Formulation 01B)
Cutaneous emulsion 200µl once a day (26 days)
|
| Experimental: 2 |
Drug: Ciclosporin 1.5% (Formulation 02B)
Cutaneous emulsion 200µl once a day (26 days)
|
| Active Comparator: 3 |
Drug: 0.1% betamethasone
Solution 200µl once a day (26 days)
Other Name: Betnesol V crinale 0.1%
|
| Active Comparator: 4 |
Drug: 0.005% calcipotriol
Solution 200µl once a day (26 days)
Other Name: Daivonex solution 0.005%
|
| Placebo Comparator: 5 |
Drug: Formulation 00B
Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)
|
Psoriasis is a common dermatological disorder, consisting of both an inflammatory and a hyperproliferative component. Scaly, erythematous infiltrated skin lesions are indicative of psoriasis vulgaris. The disease is characterized micromorphologically by epidermal hyperplasia with incomplete differentiation, intraepidermal accumulation of polymorphonuclear neutrophils, elongated papillae containing dilated, tortuous capillaries and lymphohistiocytic infiltrate.
Since the underlying cause of the disease remains unknown, causal therapy is not possible. The complex clinical picture necessitates a polypragmatic therapeutic approach. Typical therapies include phototherapy and photochemotherapy, topical treatment with corticosteroids, vitamin D3 analogs, coal-tar preparations and dithranol, and systemic treatment with retinoids, methotrexate and ciclosporin (oral or injection).
In the present study the topical cutaneous ciclosporin formulation for topical treatment of psoriasis will be tested in low-dose for efficacy and tolerability. Two concentrations of the ciclosporin formulation (0.5% and 1.5%), the corresponding vehicle, a marketed corticoid preparation and a marketed topical Vitamin-D-analog will be tested simultaneously in the same patient. Five test fields located at the torso and at the extremities will be examined per subject, and will be treated non-occlusively on 22 study days over a period study of 26 days.
Experimental measurements (sonography) and clinical assessments will be performed at baseline and on some study days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | ISDIN |
| ClinicalTrials.gov Identifier: | NCT00578370 History of Changes |
| Other Study ID Numbers: | ISD001-CI-07, 2007-002947-26 |
| Study First Received: | December 20, 2007 |
| Last Updated: | November 4, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Ciclosporin Plaque type psoriasis Psoriasis plaque test |
Sonography Cyclosporin Psoriasis |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Cyclosporins Cyclosporine Calcipotriene Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents |
Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |
