Clinical trial NCT00539929: Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
Official title: Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.


Eligibility criteria: INCLUSION CRITERIA:

* Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening
* Female participants postmenopausal \>1 year or surgically sterile
* Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm\^2), up to 50 cm\^2 in surface area
* Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus
* Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs
* Participants able and willing to give informed consent

EXCLUSION CRITERIA

* Use of any, concomitant, topical treatment for psoriasis, excluding emollients
* Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light
* Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities
* Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.

Primary outcomes:
measure: Total Symptom Severity (TSS) at week 8.
timeFrame: 8 weeks
Secondary outcomes:
measure: Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Boise
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Clinton Township
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Carlstadt
country: United States
state: New Jersey
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Lynchburg
country: United States
state: Virginia
Study officials:
affiliation: Eisai Inc.
name: Eisai US Medical Services
role: STUDY_DIRECTOR
References: