This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.
This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens. Variables to be considered in the design of cohorts include frequency of application and duration of application. The maximum duration of a treatment period is 12 weeks for any subject. 35 Subjects have been enrolled to date in the following 7 cohorts: Cohort 1: SM-020 gel 1.0% BID (Bis in die) for 14 days Cohort 2: SM-020 gel 1.0% BID for 28 days Cohort 3: SM-020 gel 1.0% BID pulsed dosing 4 days on/4 days off Cohort 4: SM-020 gel 1.0% BID for 28 days to facial SKs Cohort 5: SM-020 gel 1.0% TIW (Three times a week) under occlusion for 28 days Cohort 6: SM-020 gel 1.0% BID for 28 days with intertriginous SKs Cohort 7: SM-020 gel 0.1% BID for 28 days to facial SKs Anticipated subsequent cohorts to be enrolled: Cohort 8: SM-020 gel 1.0% BID for 56 days Cohort 9: SM-020 gel 1.0% BID for 28 days Cohort 10: SM-020 gel 1.0% QD (Quaque die) for 28 days Cohort 11: SM-020 gel 0.1% BID for 28 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Topical Akt Inhibitor SM-020 Gel
Zepeda Dermatologia
Santa Tecla, La Libertad Department, El Salvador
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve clearance (PLA score of 0) at final study visit
Time frame: Through 20 weeks
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Time frame: Through 20 weeks
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time frame: Through 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of subjects achieving clearance of at least 5 of all SKTLs
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs/subject, facial SKTLs/subject, truncal SKTLs/subject, intertriginous SKTLs/subject, and extremity SKTLs/subject achieving a PLA of 0
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time frame: Through 20 weeks