Molluscum Contagiosum
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSB206 4%
Twice daily
DRUGSB206 8%
Twice daily
DRUGSB206 12%
Once or twice daily
DRUGPlacebo
Once or twice daily
Sponsors
Premier Research
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be 2 years of age or older, and in good general health; * Have signed written informed consent form by a parent or legal guardian (assent form where required); * Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis; * Females 10 years of age and older must have a negative urine pregnancy test prior to randomization; * Females 10 years of age and older must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit; * Be willing and able to follow study instructions and likely to complete all study requirements.
Exclusion criteria
* Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment; * Have agminated MC that could make it difficult to provide accurate lesion counts; * Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions; * Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to count lesions; * Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to baseline; * Have received treatment for MC during the 14 days prior to baseline with podophyllotoxin, imiquimod, cantharidin, sinecatechins, topical retinoids, oral or topical zinc, or other homeopathic or OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists; * Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline; * Have MC only in periocular area; * Have MC only on the labia or penis; * Female subjects who are pregnant, planning a pregnancy or breastfeeding; * Have confirmed methemoglobin level of \>3.0% at Baseline using a pulse co-oximeter; * Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients; * Have participated in a previous study with NVN1000; * Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Complete Clearance at Week 12 | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1; Week 2; Week 4; Week 8; Week 12 | Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit. |
| Time to First Complete Clearance | Week 12 | Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate) |
| Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit |
| Mean Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Mean change from baseline in number of molluscum contagiosum lesions at each visit |
| Percent Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Percent change from baseline in number of molluscum contagiosum lesions at each visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: SB206 4% BID SB206 4% topically twice daily | 47 |
| Cohort 2: SB206 8% BID SB206 8% topically twice daily | 48 |
| Cohort 3: SB206 12% BID SB206 12% topically twice daily | 47 |
| Cohort 4: SB206 12% QD SB206 12% topically once daily | 48 |
| Placebo (Vehicle Gel) Vehicle Gel topically once or twice daily | 66 |
| Total | 256 |
Baseline characteristics
| Characteristic | Cohort 1: SB206 4% BID | Cohort 2: SB206 8% BID | Cohort 3: SB206 12% BID | Cohort 4: SB206 12% QD | Placebo (Vehicle Gel) | Total |
|---|---|---|---|---|---|---|
| Age, Customized ≥2 years of age | 47 Participants | 48 Participants | 47 Participants | 48 Participants | 66 Participants | 256 Participants |
| Baseline number of Molluscum lesions Placebo (vehicle gel) | — | — | — | — | 18.3 Molluscum lesions STANDARD_DEVIATION 14.47 | 18.3 Molluscum lesions STANDARD_DEVIATION 14.47 |
| Baseline number of Molluscum lesions SB206 | 21.7 Molluscum lesions STANDARD_DEVIATION 17.23 | 19.0 Molluscum lesions STANDARD_DEVIATION 14.37 | 18.8 Molluscum lesions STANDARD_DEVIATION 16.15 | 17.6 Molluscum lesions STANDARD_DEVIATION 16.55 | — | 19.3 Molluscum lesions STANDARD_DEVIATION 16.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 16 Participants | 8 Participants | 15 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 37 Participants | 31 Participants | 40 Participants | 51 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 40 Participants | 42 Participants | 44 Participants | 44 Participants | 58 Participants | 228 Participants |
| Region of Enrollment United States | 47 Participants | 48 Participants | 47 Participants | 48 Participants | 66 Participants | 256 Participants |
| Sex: Female, Male Female | 22 Participants | 27 Participants | 22 Participants | 25 Participants | 27 Participants | 123 Participants |
| Sex: Female, Male Male | 25 Participants | 21 Participants | 25 Participants | 23 Participants | 39 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 48 | 0 / 47 | 0 / 47 | 0 / 66 |
| other Total, other adverse events | 7 / 46 | 24 / 48 | 18 / 47 | 19 / 47 | 6 / 66 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 | 0 / 47 | 0 / 47 | 0 / 66 |
Outcome results
Primary
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
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Week 12 | 5 Participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Week 12 | 16 Participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Week 12 | 13 Participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Week 12 | 18 Participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Week 12 | 12 Participants |
Secondary
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
Population: mITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: SB206 4% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 1 | -1.5 Molluscum lesion counts | Standard Error 1.43 |
| Cohort 1: SB206 4% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 4 | -1.8 Molluscum lesion counts | Standard Error 1.8 |
| Cohort 1: SB206 4% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 8 | -5.6 Molluscum lesion counts | Standard Error 2.08 |
| Cohort 1: SB206 4% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 2 | -1.9 Molluscum lesion counts | Standard Error 1.53 |
| Cohort 1: SB206 4% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 12 | -7.2 Molluscum lesion counts | Standard Error 2.43 |
| Cohort 2: SB206 8% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 2 | -1.7 Molluscum lesion counts | Standard Error 1.45 |
| Cohort 2: SB206 8% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 4 | -6.0 Molluscum lesion counts | Standard Error 1.71 |
| Cohort 2: SB206 8% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 1 | 0 Molluscum lesion counts | Standard Error 1.33 |
| Cohort 2: SB206 8% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 12 | -12.0 Molluscum lesion counts | Standard Error 2.31 |
| Cohort 2: SB206 8% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 8 | -10.3 Molluscum lesion counts | Standard Error 2 |
| Cohort 3: SB206 12% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 12 | -9.9 Molluscum lesion counts | Standard Error 2.42 |
| Cohort 3: SB206 12% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 1 | -2.5 Molluscum lesion counts | Standard Error 1.44 |
| Cohort 3: SB206 12% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 2 | -1.8 Molluscum lesion counts | Standard Error 1.57 |
| Cohort 3: SB206 12% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 4 | -6.2 Molluscum lesion counts | Standard Error 1.82 |
| Cohort 3: SB206 12% BID | Mean Change in Molluscum Contagiosum at Each Visit | Week 8 | -7.6 Molluscum lesion counts | Standard Error 2.1 |
| Cohort 4: SB206 12% QD | Mean Change in Molluscum Contagiosum at Each Visit | Week 2 | -7.1 Molluscum lesion counts | Standard Error 1.41 |
| Cohort 4: SB206 12% QD | Mean Change in Molluscum Contagiosum at Each Visit | Week 4 | -8.7 Molluscum lesion counts | Standard Error 1.66 |
| Cohort 4: SB206 12% QD | Mean Change in Molluscum Contagiosum at Each Visit | Week 1 | -4.0 Molluscum lesion counts | Standard Error 1.27 |
| Cohort 4: SB206 12% QD | Mean Change in Molluscum Contagiosum at Each Visit | Week 12 | -12.9 Molluscum lesion counts | Standard Error 2.21 |
| Cohort 4: SB206 12% QD | Mean Change in Molluscum Contagiosum at Each Visit | Week 8 | -12.3 Molluscum lesion counts | Standard Error 1.92 |
| Placebo (Vehicle Gel) | Mean Change in Molluscum Contagiosum at Each Visit | Week 2 | -1.2 Molluscum lesion counts | Standard Error 1.23 |
| Placebo (Vehicle Gel) | Mean Change in Molluscum Contagiosum at Each Visit | Week 12 | -8.6 Molluscum lesion counts | Standard Error 1.9 |
| Placebo (Vehicle Gel) | Mean Change in Molluscum Contagiosum at Each Visit | Week 4 | -0.9 Molluscum lesion counts | Standard Error 1.43 |
| Placebo (Vehicle Gel) | Mean Change in Molluscum Contagiosum at Each Visit | Week 1 | 0.7 Molluscum lesion counts | Standard Error 1.13 |
| Placebo (Vehicle Gel) | Mean Change in Molluscum Contagiosum at Each Visit | Week 8 | -4.9 Molluscum lesion counts | Standard Error 1.65 |
Secondary
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
Population: mITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: SB206 4% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 12 | -25.3 Percentage change from baseline | Standard Error 9.65 |
| Cohort 1: SB206 4% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 2 | -4.4 Percentage change from baseline | Standard Error 8.44 |
| Cohort 1: SB206 4% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 8 | -19.2 Percentage change from baseline | Standard Error 9.54 |
| Cohort 1: SB206 4% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 4 | -3.6 Percentage change from baseline | Standard Error 8.19 |
| Cohort 1: SB206 4% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 1 | 0.0 Percentage change from baseline | Standard Error 7.82 |
| Cohort 2: SB206 8% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 2 | 5.8 Percentage change from baseline | Standard Error 8.07 |
| Cohort 2: SB206 8% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 8 | -47.5 Percentage change from baseline | Standard Error 9.17 |
| Cohort 2: SB206 8% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 1 | 10.1 Percentage change from baseline | Standard Error 7.33 |
| Cohort 2: SB206 8% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 12 | -64.3 Percentage change from baseline | Standard Error 9.07 |
| Cohort 2: SB206 8% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 4 | -30.4 Percentage change from baseline | Standard Error 7.75 |
| Cohort 3: SB206 12% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 4 | -29.2 Percentage change from baseline | Standard Error 8.32 |
| Cohort 3: SB206 12% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 8 | -38.7 Percentage change from baseline | Standard Error 9.64 |
| Cohort 3: SB206 12% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 12 | -56.1 Percentage change from baseline | Standard Error 9.61 |
| Cohort 3: SB206 12% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 2 | -5.9 Percentage change from baseline | Standard Error 8.64 |
| Cohort 3: SB206 12% BID | Percent Change in Molluscum Contagiosum at Each Visit | Week 1 | -4.7 Percentage change from baseline | Standard Error 7.84 |
| Cohort 4: SB206 12% QD | Percent Change in Molluscum Contagiosum at Each Visit | Week 12 | -54.6 Percentage change from baseline | Standard Error 8.7 |
| Cohort 4: SB206 12% QD | Percent Change in Molluscum Contagiosum at Each Visit | Week 1 | -11.1 Percentage change from baseline | Standard Error 6.96 |
| Cohort 4: SB206 12% QD | Percent Change in Molluscum Contagiosum at Each Visit | Week 2 | -29.2 Percentage change from baseline | Standard Error 7.81 |
| Cohort 4: SB206 12% QD | Percent Change in Molluscum Contagiosum at Each Visit | Week 4 | -37.3 Percentage change from baseline | Standard Error 7.54 |
| Cohort 4: SB206 12% QD | Percent Change in Molluscum Contagiosum at Each Visit | Week 8 | -56.3 Percentage change from baseline | Standard Error 8.79 |
| Placebo (Vehicle Gel) | Percent Change in Molluscum Contagiosum at Each Visit | Week 8 | -17.2 Percentage change from baseline | Standard Error 7.58 |
| Placebo (Vehicle Gel) | Percent Change in Molluscum Contagiosum at Each Visit | Week 4 | -6.6 Percentage change from baseline | Standard Error 6.51 |
| Placebo (Vehicle Gel) | Percent Change in Molluscum Contagiosum at Each Visit | Week 2 | -4.1 Percentage change from baseline | Standard Error 6.77 |
| Placebo (Vehicle Gel) | Percent Change in Molluscum Contagiosum at Each Visit | Week 1 | 8.7 Percentage change from baseline | Standard Error 6.16 |
| Placebo (Vehicle Gel) | Percent Change in Molluscum Contagiosum at Each Visit | Week 12 | -37.8 Percentage change from baseline | Standard Error 7.54 |
Secondary
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
Population: mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 4 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 4 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 10 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 8 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 14 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 20 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 6 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 9 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 18 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 20 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 22 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 20 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 9 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 8 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 5 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 11 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 1 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 18 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 3 participants |
Secondary
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
Population: mITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 0 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 5 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 1: SB206 4% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 7 participants |
| Cohort 2: SB206 8% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 16 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 0 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 10 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 3 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 3: SB206 12% BID | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 13 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 11 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 5 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 18 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 1 participants |
| Cohort 4: SB206 12% QD | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 3 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 12 proportion of subjects achieving complete clearance. | 12 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1 proportion of subjects achieving complete clearance. | 0 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 4 proportion of subjects achieving complete clearance. | 2 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 8 proportion of subjects achieving complete clearance. | 6 participants |
| Placebo (Vehicle Gel) | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 2 proportion of subjects achieving complete clearance. | 1 participants |
Secondary
Time to First Complete Clearance
Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
Time frame: Week 12
Population: mITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: SB206 4% BID | Time to First Complete Clearance | NA Days |
| Cohort 2: SB206 8% BID | Time to First Complete Clearance | 100.0 Days |
| Cohort 3: SB206 12% BID | Time to First Complete Clearance | 91.0 Days |
| Cohort 4: SB206 12% QD | Time to First Complete Clearance | 85.0 Days |
| Placebo (Vehicle Gel) | Time to First Complete Clearance | 93.0 Days |