Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05136144
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2021-11-08
Brief Title:
Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
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 10 and 01 Gel Formulations in Subjects With Seborrheic Keratosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10 BID Bis in die for 14 days
Cohort 2 SM-020 gel 10 BID for 28 days
Cohort 3 SM-020 gel 10 BID pulsed dosing 4 days on4 days off
Cohort 4 SM-020 gel 10 BID for 28 days to facial SKs
Cohort 5 SM-020 gel 10 TIW Three times a week under occlusion for 28 days
Cohort 6 SM-020 gel 10 BID for 28 days with intertriginous SKs
Cohort 7 SM-020 gel 01 BID for 28 days to facial SKs
Anticipated subsequent cohorts to be enrolled
Cohort 8 SM-020 gel 10 BID for 56 days
Cohort 9 SM-020 gel 10 BID for 28 days
Cohort 10 SM-020 gel 10 QD Quaque die for 28 days
Cohort 11 SM-020 gel 01 BID for 28 days
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 10 BID Bis in die for 14 days
Cohort 2 SM-020 gel 10 BID for 28 days
Cohort 3 SM-020 gel 10 BID pulsed dosing 4 days on4 days off
Cohort 4 SM-020 gel 10 BID for 28 days to facial SKs
Cohort 5 SM-020 gel 10 TIW Three times a week under occlusion for 28 days
Cohort 6 SM-020 gel 10 BID for 28 days with intertriginous SKs
Cohort 7 SM-020 gel 01 BID for 28 days to facial SKs
Anticipated subsequent cohorts to be enrolled
Cohort 8 SM-020 gel 10 BID for 56 days
Cohort 9 SM-020 gel 10 BID for 28 days
Cohort 10 SM-020 gel 10 QD Quaque die for 28 days
Cohort 11 SM-020 gel 01 BID for 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None