This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.
This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in up to approximately 192 or 256 non-immunocompromised subjects with molluscum contagiosum. Subjects who satisfy entry criteria will be randomized 3:1 to ascending, sequential dose cohorts of SB206. The highest tolerated dose will also be run in a cohort once daily. Approximately 64 subjects will be randomized to each cohort. Subjects will be treated once daily, twice daily or three times a week for up to 12 weeks. After 30 subjects randomized in a cohort have completed 2 weeks of treatment, the Data Safety Monitoring Board (DSMB) will review the available unblinded safety and tolerability data. The DSMB will determine if the data supports escalating to the next highest dose for the next cohort or if the data shows the dose is not tolerable decreasing to the next lower dose or frequency for the next cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
Premier Site# 266
Scottsdale, Arizona, United States
Premier Site# 260
Santa Ana, California, United States
Proportion of Subjects Achieving Complete Clearance at Week 12
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
Time frame: 12 weeks
Proportion of Subjects Achieving Complete Clearance at Each Visit
Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
Time frame: Week 1; Week 2; Week 4; Week 8; Week 12
Time to First Complete Clearance
Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
Time frame: Week 12
Proportion of Subjects Achieving 75% Reduction at Each Visit
Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Mean Change in Molluscum Contagiosum at Each Visit
Mean change from baseline in number of molluscum contagiosum lesions at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Percent Change in Molluscum Contagiosum at Each Visit
Percent change from baseline in number of molluscum contagiosum lesions at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
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Once or twice daily
Premier Site# 257
Thornton, Colorado, United States
Premier Site# 264
Doral, Florida, United States
Premier Site# 116
Newnan, Georgia, United States
Premier Site# 251
Indianapolis, Indiana, United States
Premier Site# 253
Lenexa, Kansas, United States
Premier Site# 117
Louisville, Kentucky, United States
Premier Site# 182
Las Vegas, Nevada, United States
Premier Site# 252
Norman, Oklahoma, United States
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