The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Etanercept for subcutaneous injection.
Placebo for subcutaneous injection.
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
Time frame: Baseline and Week 12
Percentage of Participants With PSSI 75% Response at Week 12
Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.
Time frame: Baseline and Week 12
Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12
Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.
Time frame: Baseline and Week 24
Patient Satisfaction With Treatment at Week 12
This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from "very dissatisfied" to "very satisfied") to indicate his or her level of satisfaction with the medication's control of psoriasis.
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Time frame: 12 Weeks