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:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00539929
First received: October 3, 2007
Last updated: November 4, 2013
Last verified: November 2013

October 3, 2007
November 4, 2013
September 2007
June 2008   (final data collection date for primary outcome measure)
Total Symptom Severity (TSS) at week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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. PK samples will be obtained pre-and post treatment.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Plaque Psoriasis
  • Drug: E6201
    Cream, twice daily.
  • Drug: E6201
    Cream, once daily.
  • Placebo Comparator: 1
    Intervention: Drug: E6201
  • Placebo Comparator: 2
    Intervention: Drug: E6201
  • Placebo Comparator: 3
    Intervention: Drug: E6201
  • Placebo Comparator: 4
    Intervention: Drug: E6201
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 or Females, ≥18 years of age.
  • Mild to moderate plaque-type psoriasis > 1 year.
  • Two representative marker lesions of similar size (15 to 25 cm^2 to 50 cm^2) must be present.

EXCLUSION CRITERIA

  • Use of any, concomitant treatment (topical and systemic) for psoriasis, excluding emollients. Psoriasis medications will require a wash-out prior to study entry.
  • Evidence of any clinically significant deviation from normal with regard to medical history, 12-lead ECG or laboratory determinations.
  • Presence of skin disease other than plaque type psoriasis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00539929
E6201-A001-201
No
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai US Medical Services Eisai Inc.
Eisai Inc.
November 2013

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