This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Apply topically twice daily for 12 consecutive weeks
Apply topically twice daily for 12 consecutive weeks
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Percentage of participants achieving a 50% improvement from baseline in psoriasis area and severity index (PASI 50) score at week 8
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections \[head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)\]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.
Time frame: 8 weeks
PASI 50 score at each visit through week 12 (except week 8)
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections \[head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)\]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.
Time frame: Baseline to week 12 (except week 8)
Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections \[head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)\]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.
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Time frame: Baseline to week 12
Change PASI score at each visit from baseline through week 12
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections \[head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)\]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time frame: Baseline to week 12
Percentage of participants achieving the physician global assessment (PGA) of psoriasis responses of clear (0) or almost clear (1) and ≥2 grade improvement at each visit through week 12
PGA of Psoriasis: score based on dermatologist's assessment of skin disease averaged over all lesions. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). Higher scores indicate greater severity of disease.
Time frame: Baseline to week 12
Lesion severity
Lesion severity includes the sum of 3 indications, e.g. Erythema, scaling, thickness of target psoriasis site on patients with mild to moderate psoriasis. Each indication is scored from 0 (not at all serious) to 4 (very serious).
Time frame: Baseline to week 12