A Phase 2 interventional study of SM-020 gel 1.0% and Vehicle gel in Seborrheic Keratosis, sponsored by DermBiont, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by DermBiont, Inc. · Phase 2, Interventional, and Treatment
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →DermBiont, Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Subjects must meet all of the following criteria to be included in the study:
Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 SKTLs will be targeted for treatment. An eligible SKTL must :
Exclusion Criteria:
Subjects meeting any of the following criterion will be ineligible and excluded from this study:
Any use of the following systemic therapies within the specified period, or unwilling to meet the following washouts, prior to the Baseline visit and while on study:
Any use of the following topical therapies within the specified period, or unwilling to meet the following washouts, prior to the Baseline visit and while on study, on or in a proximity to any SKTL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
Occurrence or presence of any of the following within the specified period prior to the Baseline visit on or in the proximity of any SKTL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
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.
Drug: SM-020 gel 1.0%
Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.
Drug: Vehicle gel
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.
Superiority 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.
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
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DermBiont, Inc.