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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539929
First Posted: October 5, 2007
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
October 3, 2007
October 5, 2007
February 6, 2017
September 2007
June 2008   (Final data collection date for primary outcome measure)
Total Symptom Severity (TSS) at week 8. [ Time Frame: 8 weeks ]
Total Symptom Severity (TSS) at week 8.
Complete list of historical versions of study NCT00539929 on ClinicalTrials.gov Archive Site
Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK) [ Time Frame: Up to 12 weeks ]
Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)
Not Provided
Not Provided
 
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Plaque Psoriasis
  • Drug: E6201 0.005%
  • Drug: E6201 0.01%
  • Drug: E6201 0.03%
  • Drug: Placebo
  • Experimental: E6201 0.005% BID
    Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
    Interventions:
    • Drug: E6201 0.005%
    • Drug: Placebo
  • Experimental: E6201 0.01% BID
    Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
    Interventions:
    • Drug: E6201 0.01%
    • Drug: Placebo
  • Experimental: E6201 0.03% BID
    Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
    Interventions:
    • Drug: E6201 0.03%
    • Drug: Placebo
  • Experimental: E6201 0.03% QD
    Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen.
    Interventions:
    • Drug: E6201 0.03%
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00539929
E6201-A001-201
No
Not Provided
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai US Medical Services Eisai Inc.
Eisai Inc.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP