Study of SM-020 Gel for Seborrheic Keratoses and Non-Melanoma Skin Cancers
This study is testing a gel called SM-020 1.0% for people with seborrheic keratoses (common, non-cancerous skin growths) and non-melanoma skin cancers, specifically basal cell carcinoma and squamous cell carcinoma in situ (early-stage skin cancer). Researchers want to see how safe and effective SM-020 gel is when applied to these skin conditions. You might be able to join if you are 18 or older and have at least one eligible skin lesion. The study will measure success by looking at the percentage of lesions that shrink by at least 50% after 6 weeks. The study status is currently unclear, meaning it may or may not be actively recruiting participants.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving SM-020 gel. About 50 participants will be enrolled into 5 different groups.
- What's involved
- You would apply SM-020 gel to up to 5 lesions twice a day for 28 days. You will have visits at screening, baseline, and then weekly for four weeks, followed by visits at week 6 and week 8.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and the size of your lesions will be checked for up to 8 weeks after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baselineAt week 6
- Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Application Site Reactions will be evaluated based on the severity of the signs and symptoms of pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation,and hypopigmentation.
- Safety and Tolerability as evaluated by review of adverse eventsScreening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Grade 1 = Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 = Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 = Life-threatening consequences: urgent intervention indicated Grade 5 = Death related to AE with Grade 1 being the minimum value and Grade 5 being the maximum value, with a higher value indicating higher severity.