The objective of the trial is to evaluate the safety and efficacy of SM-020 gel 1.0% in subjects with Seborrheic Keratosis (SK) compared to vehicle gel. It is a randomized, double-blind, vehicle-controlled trial. Approximately 60 subjects will be enrolled. Subjects will apply their assigned investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12-weeks post final application for a total of approximately 16-weeks of required participation in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.
Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.
Driven Research LLC
Coral Gables, Florida, United States
RECRUITINGMinnesota Clinical Study Center
New Brighton, Minnesota, United States
RECRUITINGOregon Medical Research Center
Portland, Oregon, United States
RECRUITINGOregon Dermatology and Research Center
Portland, Oregon, United States
RECRUITINGSuperiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0
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)
Time frame: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, and Week 16
Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic Keratosis
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.
Time frame: Through week 16 (Visit 9)
Safety and Tolerability as evaluated by review of adverse events
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.
Time frame: Through week 16 (Visit 9)
Superiority of active over vehicle as measured by the percentage of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16
Superiority of active over vehicle, based on the time to all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs achieving a PLA of 0
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of at least 60% of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLS, and extremity SKTLs
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs/subject, facial SKTLs/subject, truncal SKTLs/subject, intertriginous SKTLs/subject, and extremity SKTLs/subject achieving a PLA of 0
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
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Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16
Superiority of active over vehicle as measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Time frame: Through week 16