Chronic stable plaque psoriasis with one or two stable psoriatic plaque(s) suitable in size and location for five separate treatment fields to be assessed within it. MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: E6201 0.03% Gel
Product Code: E6201
Pharmaceutical Form: Gel
CAS Number: 603978-35-5
Current Sponsor code: E6201
Concentration unit: % percent
Concentration type: equal
Concentration num
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: 1.Males and females aged between 18 and 75 years of age 2.Subjects with chronic stable plaque psoriasis with one or two stable psoriatic plaque(s) suitable in size and location for 5 separate treatment fields to be assessed within it; 3.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; 4.Females of childbearing potential must have a negative serum ßhCG 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 with a failure rate of less than 1 % per year when used consistently and correctly (eg, implants, injectables, combined oral contraceptives, condom + spermicide, condom + diaphragm with spermicide, some intra uterine devices (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 Days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; 5.Willing and able to comply with all aspects of the protocol; 6.Provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from participation in the study: 1.Females who are pregnant (positive ß-hCG test) or breastfeeding; 2.Any other clinically significant skin diseases as determined by the investigator other than chronic stable plaque psoriasis; 3.Any other types of psoriasis other than chronic stable plaque variant e.g. guttate, pustular, erythrodermic, etc; 4.An unstable course of psoriatic disease as defined by flare(s) or spontaneous remissions in the previous month. A flare is defined as clinically significant worsening of erythema induration or affected surface area. 5.Subjects who used any of the following systemic treatments within 12 weeks before the Baseline visit: 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. 6.Subjects who have used any concomitant topical treatment for the psoriatic plaque(s) to be studied, (other than emollients or salicylic acid) within 8 weeks before the Baseline Visit e.g. corticosteroids or topical immunomodulators, anthralin (dithranol), Vitamin D derivatives, ultraviolet-light therapy including sunbathing, or retinoids; 7.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, ß-blockers, antimalarial drugs, and lithium within two weeks before the Baseline visit; 8.Subject with hypersensivity to E6201 gel and/or any of the excipients; 9.Contraindications according to summary of product characteristic of Daivonex® Cream 0.005%20 10.Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject’s ability to safely complete the study; 11.Any clinically-significant abnormal laboratory test taht, in the opinion of the investigator, would compromise the subject's ability to safely complete the study; 12.The Investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason; 13.History of drug or alcohol dependency or abuse within approximately the last 2 years; 14.Scheduled for surgery during the projected course of the study; 15.Subjects planning a significant exposure to sun (sun-bathing); 16.Subject is a dependent person, i.e a relative / family member of the investigator and / or is a member of the investigator’s staff; 17.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; 18.In the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; 19.Subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that at least one concentration of topical E6201 gel has superior efficacy compared with vehicle on the reduction of psoriatic infiltrate thickness during 12 Days of treatment in subjects with psoriasis vulgaris;Secondary Objective: •To evaluate the safety and tolerability of six topical concentrations of E6201 gel as measured by rates of adverse events, and relative to vehicle •To explore the concentration/response relationship;Primary end point(s): The primary efficacy variable is the area under the curve (AUC) for baseline-corrected thickness of the psoriatic infiltrate (20 MHz sonographic measurement) for each treatment field. This is calculated by applying the linear trapezoidal rule. . | — |
Countries
Germany
Outcome results
None listed