Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test
Information source: ISDIN
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Ciclosporin 0.5% (Formulation 01B) (Drug); Ciclosporin 1.5% (Formulation 02B) (Drug); 0.1% betamethasone (Drug); 0.005% calcipotriol (Drug); Formulation 00B (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: ISDIN Official(s) and/or principal investigator(s): Johannes Gassmueller, MD, Principal Investigator, Affiliation: Bioskin GmbH
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Psoriatic infiltrate measured by sonography
Secondary outcome: Skin condition measured by scoring
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with chronic plaque type psoriasis
- Sexually active females of childbearing potential should either be surgically sterile
(hysterectomy or tubal ligation), or should use a highly effective medically accepted
contraceptive regimen
Exclusion Criteria:
- Local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4
weeks preceding and during the study (corticosteroids 8 weeks)
- Systemic treatment with antipsoriatics or therapy with PUVA, selected ultraviolet
photo therapy in the three months preceding and during the study
- Treatment with systemic or locally acting medications which might counter or
influence the study aim
- Previous therapy with methotrexate over many years
- Therapy with nephrotoxic medication
- Therapy with digoxin, colchicin and statins
- Medications which might influence the potassium metabolism
- Subjects with known dysfunction of the calcium metabolism
- Subjects with increased uric acid or potassium serum levels
- Erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended
chronic stationary forms of psoriasis
- Subjects with acute virus infection
- Subjects with acne, anogenital pruritus, rosacea, perioral dermatitis, specific skin
problems (skin tuberculosis, luetic skin diseases), vaccination reactions, skin
infections caused by bacteria or viruses
- Symptoms of a clinically significant illness that may influence the outcome of the
study in the four weeks before and during the study
Locations and Contacts
Bioskin, Hamburg 20095, Germany
Additional Information
Related publications: Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. Wendt H, Frosch PJ. Psoriasis-Plaque Test. 31 - 35 in: Clinico-pharmacological models for the assay of topical corticoids. Wendt H, Frosch PJ (eds.) 1982, Karger Verlag, Basel
Starting date: November 2007
Last updated: November 4, 2008
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