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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00539929
Other study ID # E6201-A001-201
Secondary ID
Status Completed
Phase Phase 2
First received October 3, 2007
Last updated February 3, 2017
Start date September 2007
Est. completion date July 2008

Study information

Verified date January 2017
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
E6201 0.005%

E6201 0.01%

E6201 0.03%

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Symptom Severity (TSS) at week 8. 8 weeks
Secondary Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK) Up to 12 weeks
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