Molluscum Contagiosum
Conditions
Brief summary
This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study.
Detailed description
This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in approximately 340 subjects with MC. After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 2:1 (active:vehicle). Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study. Subjects or their caregivers will continue to treat the area until the next scheduled visit even if the lesion(s) clear. If the investigator determines all lesions are cleared at a clinic visit, the treatment may stop. Subjects will visit the clinic at Screening/Baseline, Week 2, Week 4, Week 8, Week 12. In addition, subjects will be seen in the clinic for a safety follow-up at Week 24.
Interventions
DRUGSB206 12%
Topically once daily
DRUGPlacebo
Topically once daily
Sponsors
Synteract, Inc.
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Be 6 months of age or older, and in good general health; * Have a written informed consent form signed by subject or a parent or legal guardian and an assent form as required; * Have between 3 and 70 treatable MC at Baseline; * Female subjects age 9 and above must have a negative UPT at Baseline; * Female subjects age 9 and above must agree to practice a medically acceptable form of birth control during the study and for 30 days after Week 12/ET1; * Be willing and able to follow study instructions and likely to complete all study requirements.
Exclusion criteria
* Have strongly suggested sexually transmitted MC and do not agree to refrain from sexual activities throughout the study period. * Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment; * Have significant injury on and/or surrounding MC that may impact ability to treat and 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 over the counter (OTC) products including, but not limited to, ZymaDerm and tea tree oil, cimetidine and other histamine H2 receptor antagonists (including Zantac); * Have received surgical procedures related to MC (cryotherapy, curettage, other) within 14 days prior to Baseline; * Have MC only in periocular area; * Female subjects who are pregnant, planning a pregnancy or breastfeeding; * Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients; * Have participated in a previous study with a berdazimer sodium product (SB204, SB206, SB208, SB414); * Have more than 1 family member currently participating in a study with a berdazimer sodium product (SB204, SB206, SB208, SB414). * Have participated in any other trial of an interventional investigational drug or device within 14 days or concurrent participation in another interventional research study. * History or presence of clinically significant medical, psychiatric, or emotional condition that, in opinion of the investigator, would compromise the safety of the subject or the quality of the data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance of All Treatable MC 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 |
|---|---|---|
| Complete Clearance of All Treatable MC at Week 8 | 8 Weeks | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable). |
Countries
United States
Participant flow
Recruitment details
The recruitment period began June 3, 2019 and ended on August 2, 2019.
Pre-assignment details
Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| SB206 12% SB206 12% topically once daily
SB206 12%: Topically once daily | 235 |
| Placebo Placebo topically once daily
Placebo: Topically once daily | 116 |
| Total | 351 |
Baseline characteristics
| Characteristic | Placebo | Total | SB206 12% |
|---|---|---|---|
| Age, Customized 12 years old to 18 years old | 7 participants | 24 participants | 17 participants |
| Age, Customized 18 years old | 2 participants | 8 participants | 6 participants |
| Age, Customized 1 to 2 years old | 1 participants | 9 participants | 8 participants |
| Age, Customized <1 year old | 0 participants | 0 participants | 0 participants |
| Age, Customized 2 years old to 6 years old | 59 participants | 158 participants | 99 participants |
| Age, Customized 6 years old to 12 years old | 47 participants | 152 participants | 105 participants |
| Baseline number of Molluscum lesions | 18.6 Molluscum lesions STANDARD_DEVIATION 15.41 | 18.1 Molluscum lesions STANDARD_DEVIATION 14.38 | 17.8 Molluscum lesions STANDARD_DEVIATION 13.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 102 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 249 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 27 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 100 Participants | 306 Participants | 206 Participants |
| Region of Enrollment United States | 116 Participants | 351 Participants | 235 Participants |
| Sex: Female, Male Female | 49 Participants | 168 Participants | 119 Participants |
| Sex: Female, Male Male | 67 Participants | 183 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 116 |
| other Total, other adverse events | 86 / 235 | 20 / 116 |
| serious Total, serious adverse events | 0 / 235 | 0 / 116 |
Outcome results
Primary
Complete Clearance of All Treatable MC 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: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB206 | Complete Clearance of All Treatable MC at Week 12 | 61 Participants |
| Placebo | Complete Clearance of All Treatable MC at Week 12 | 25 Participants |
Secondary
Complete Clearance of All Treatable MC at Week 8
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable).
Time frame: 8 Weeks
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB206 | Complete Clearance of All Treatable MC at Week 8 | 36 Participants |
| Placebo | Complete Clearance of All Treatable MC at Week 8 | 12 Participants |