a 12-day randomized, blinded, vehicle and active comparator-controlled study to determine the efficacy and safety of six concentrations of topical e6201 gel in subjects with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of e6201 in subjects with psoriasis vulgaris.

this is a single center, randomized, blinded, intra-individual comparison in two sequential cohorts of 15 subjects each (30 subjects in total) in an outpatient setting, in which each subject simultaneously receives five topical treatments (3 active, 1 vehicle, and 1 positive control) within one or two psoriatic plaques. treatments consisted of 3 concentrations of e6201 gel, a negative control (gel vehicle), and a positive control (0.005% calcipotriene cream). the different concentrations of e6201 gel and vehicle control were double-blinded, while the calciprotriene cream was single-blinded. cohort 2 participants were not dosed until all participants in cohort 1 completed treatment and safety data were collected and evaluated.

Eligibility criteria:
inclusion: * chronic stable plaque psoriasis with one or two stable psoriatic plaques(s) suitable in size and location for five separate treatment fields to be assessed within it. * males and females aged between 18 and 75 years of age * the general physical examination should be normal (excluding the skin examination for psoriasis) unless the investigator considers an abnormality not to be clinically significant with regard to the study * females of childbearing potential must have a negative serum beta-human chorionic gonadotropin at visit 1 (screening) and a negative urine pregnancy test prior to starting study drug(s) (visit 2). female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception throughout the study period and for 30 days after the last dose of study drug. * provide written informed consent * willing and able to comply with all aspects of the protocol exclusion: * any clinically significant skin diseases other then chronic stable plaque psoriasis * other types of psoriasis than chronic stable plaque variant eg, guttate, pustular, erythodermic, etc * an unstable course of the disease defined as flare(s) in the previous month * subjects who used any concommitant topical treatment for the psoriatic plaque(s) to be studied (other than emollients or salicylic acid) within 8 weeks before the baseline visit eg corticosteroids or topical immunomodulators, anthralin (dithranil), vitamin d derivatives, ultraviolet-light therapy including sunbathing , or retinoids. * subjects who used any of the following systemic treatments within 12 weeks before the baseline visit eg: corticosteroids or adrenocorticotrophic hormone analogs, retinoids such as acitretin or isotretinoin, cyclosporin, interferon, methotrexate, other immuno-suppressive/immunomodulating drugs, psoralen and ultraviolet a therapy, or biologics * subjects planning on significant exposure to sun (sun-bathing) * treatment with systemic or locally acting medications which might counter or influence the study aim (eg monoamine oxidase inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, eg beta-blockers, antimalarial drugs, and lithium within two weeks before the baseline visit * subject is a dependent person, ie, a relative/family member of the investigator and/or is a member of the investigator's staff * clinical study participation with any investigational drug less than 30 days prior to study entry or planning to receive an investigational drug during the study period

Keywords: psoriasis vulgaris