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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 is ongoing, but not recruiting participants.

Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00539929
  Purpose

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.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: E6201
Phase II

MedlinePlus related topics:   Psoriasis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Total Symptom Severity (TSS) at week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   100
Study Start Date:   September 2007
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator Drug: E6201
Cream, twice daily.
2: Placebo Comparator Drug: E6201
Cream, twice daily.
3: Placebo Comparator Drug: E6201
Cream, twice daily.
4: Placebo Comparator Drug: E6201
Cream, once daily.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539929

Locations
United States, Texas
Dr. Terry Jones, M.D.    
      Bryan, Texas, United States, 77802

Sponsors and Collaborators
Eisai Medical Research Inc.

Investigators
Study Director:     Michael Kuligowski, MD     Eisai Medical Research Inc.    
  More Information

Responsible Party:   Eisai Medical Research Inc. ( Ger Rikken, M.D., Study Director )
Study ID Numbers:   E6201-A001-201
First Received:   October 3, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00539929
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 05, 2008




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