Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline
Timeframe: At week 6
Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)
Timeframe: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Safety and Tolerability as evaluated by review of adverse events
Timeframe: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8