Spots Global Cancer Trial Database for Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

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Trial Identification

Brief Title: Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

Official Title: Open-Label Adaptive Design Study to Explore the Safety and Efficacy of Multiple Treatment Regimens With the Akt Inhibitor SM-020 Gel in 1.0% and 0.1% Gel Formulations in Subjects With Seborrheic Keratosis

Study ID: NCT05136144

Conditions

Seborrheic Keratosis

Interventions

SM-020

Study Description

Brief Summary: 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.

Detailed Description: 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