A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
A well-characterized botanical drug for the topical treatment of psoriasis vulgaris. The drug has been approved by the NMPA in China and has obtained an NDA following multiple clinical trials spanning phases I-III in large cohorts.
Vehicle
Department of Dermatology, State University of New York, Downstate Medical Center
New York, New York, United States
Dermatology Associates
Seattle, Washington, United States
Investigator's Static Global Assessment Scale (ISGA) Scores
ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
Time frame: Baseline and 8 weeks after treatment
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores
PASI is the most widely used tool to measure psoriasis severity, combining the severity of lesions (erythema, induration, and desquamation) and the affected area into a single score. Scale ranges from 0 (no disease) to 72 (maximal disease). A PASI 75% represents a 75% reduction from baseline, indicating a substantial improvement in psoriasis symptoms.
Time frame: Baseline and 8 weeks after treatment
Dermatology Life Quality Index (DLQI) Scores
DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life.
Time frame: Baseline and 8 weeks
Psoriasis Disability Index Questionnaire (PDI) Scores
PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life.
Time frame: Baseline and 8 weeks
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