Efficacy and Tolerability Study of Topical Ciclosporin in a Psoriasis Plaque Test
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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.