To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area.
A double-blind, randomized,vehicle-controlled, parallel-group, and dose-ranging study to evaluate the efficacy and safety of SR-T100 gel in patients with EGW(s). The primary efficacy endpoint will be defined as the proportion of patients whose baseline EGW(s) on the treated area achieve total clearance. The efficacy of SR-T100 gel in prevention of new EGW(s) occurrence will be evaluated. Distinct to existing medications for EGWs, SR-T100 gel possesses characteristics of high safety and low LSR causality. SR-T100 gel will be administered on EGW lesion(s) for clearance and on the surrounding clinical normal skin for prevention of new EGW(s) occurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
138
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Total clearance rate of baseline lesion(s)
Time frame: 16 weeks
Total clearance rate of all lesion(s)
Time frame: 16 weeks
Period duration of achieving total clearance of baseline lesion(s) and new lesion(s)
Time frame: 16 weeks
Partial clearance rate
Time frame: 16 weeks
New lesion(s) occurrence rate
Time frame: 16 weeks
Recurrence rate in the 12-week follow-up time
Time frame: 28 weeks
Recurrence time period
Time frame: 28 weeks
Safety: evaluate the changes occurring from baseline to EOT visit
including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.
Time frame: 28 weeks
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