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Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test

NCT00578370 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2008-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ciclosporin 0.5% (Formulation 01B)

Cutaneous emulsion 200µl once a day (26 days)

DRUG

Ciclosporin 1.5% (Formulation 02B)

Cutaneous emulsion 200µl once a day (26 days)

DRUG

0.1% betamethasone

Solution 200µl once a day (26 days)

DRUG

0.005% calcipotriol

Solution 200µl once a day (26 days)

DRUG

Formulation 00B

Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)

Sponsors & Collaborators

  • ISDIN

    lead INDUSTRY

Principal Investigators

  • Johannes Gassmueller, MD · Bioskin GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578370 on ClinicalTrials.gov