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NCT Number: NCT00539929

Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hot Springs, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E6201 0.005%

Drug

E6201 0.01%

Drug

E6201 0.03%

Drug

Placebo

Drug

Primary outcomes

  1. Total Symptom Severity (TSS) at week 8.

    Time frame: 8 weeks

Secondary outcomes

  1. Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 5, 2007
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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