This protocol describes randomized, multicenter, blinded (subjects), 16-week, controlled study in parallel balanced groups of psoriasis (Ps) patients to evaluate the impact of Mind.Px on response to biologic treatments. Patients enrolled in this study will be required to have diagnosis of Ps and a total score ≥10 on the PASI and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4. Patients suffering from Ps will be enrolled in the study and randomized on a 1:1 basis to treatment as usual (TAU) or to treatment decision utilizing Mind.Px (MND). Both groups will have a dermal patch applied and analyzed. The TAU group will not be provided the results of the dermal patch until the end of the last study visit. The MND group will be provided the results of the dermal patch upon the completion of the analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
200
Use of Mind.Px report as a reference for potential better matching of biologics to patients.
Evaluate the impact of Mind.Px on response to biologic treatment as judged by the mean change in the Psoriasis Area Severity index (PASI) score from baseline to end of Week 16 of the study.
Evaluate the impact of Mind.Px on response to biologic treatment as judged by the mean change in the Psoriasis Area Severity index (PASI) score from baseline to end of Week 16 of the study.
Time frame: 16 weeks
Mean change in the Physician Global Assessment (PGA) by the Body Surface Area (BSA), or Dermatology Life Quality Index (DLQI) from baseline to end of Week 16 of the study
Mean change in the Physician Global Assessment (PGA) by the Body Surface Area (BSA), or Dermatology Life Quality Index (DLQI) from baseline to end of Week 16 of the study
Time frame: 16 weeks
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