SM-020 Gel for Seborrheic Keratosis
This study is testing a gel called SM-020 gel 1.0% to see if it's safe and effective for treating seborrheic keratosis (SK), which are common, non-cancerous skin growths. You would apply either SM-020 gel or a vehicle gel (a gel without the active medicine) to your SK lesions twice a day for about 28 days. Researchers will compare how well the SM-020 gel works against the vehicle gel by looking at the proportion of treated lesions that clear up completely. They will also track any side effects. About 60 adults aged 18 and older can join this study. The current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, vehicle-controlled study involving about 60 participants.
- What's involved
- You would apply a gel twice daily to 5 to 10 seborrheic keratosis lesions for approximately 28 days. Your total participation in the study would be about 16 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 12 weeks after your final application of the gel, for a total of approximately 16 weeks of study participation.
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 Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
At a glance
Conditions
Where it's being run
4 sites across 3 statesWho to contact
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What this trial measures
- Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, and Week 16
The PLA is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The PLA will be determined for each SKTL at all clinic study visits from Visit 1/Screening to Visit 9/Last Visit. Physician's Lesion Assessment Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤1mm) 3. Thick: a visible seborrheic keratosis lesion (thickness \>1mm)
- Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic KeratosisThrough week 16 (Visit 9)
Application site reactions will be evaluated based on the scores for erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation by the Investigator, and the additional symptoms of pain, burning, stinging, and pruritus. Scale 0=None, 1=slight, 2=Moderate, 3=Significant with 0 being the minimum value and 3 being the maximum value, with a higher value indicating higher severity.
- Safety and Tolerability as evaluated by review of adverse eventsThrough week 16 (Visit 9)
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.