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 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% 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 up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (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 treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24.
Interventions
DRUGSB206 10.3% berdazimer
Topically once daily
DRUGvehicle gel
Topically once daily
Sponsors
Therapeutics, Inc.
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
1. Be 6 months of age or older, and in good general health; 2. Have a documented informed consent form signed by subject or a parent or legal guardian and an assent form as required; 3. Have between 3 and 70 treatable MC lesions at Baseline; 4. For women of childbearing potential (WOCBP): Must have a negative urine pregnancy test prior to randomization and must agree to use an effective method of birth control during the study; Note: WOCBP and effective methods of birth control are outlined in Section 9.4. 5. Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera; 6. Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.
Exclusion criteria
1. Have strongly suggested sexually transmitted MC and do not agree to refrain from sexual activities throughout the study period; 2. Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment; 3. Have significant injury on and/or surrounding MC that may impact ability to treat and count lesions; 4. Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to Baseline; 5. 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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies); 6. Have received surgical procedures related to MC (e.g. cryotherapy, curettage) within 14 days prior to Baseline; 7. Have MC only in periocular area; 8. Female subjects who are pregnant, planning a pregnancy or breastfeeding; 9. Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients; 10. Have participated in a previous study with a berdazimer containing product (i.e. SB204, SB206, SB208, SB414); 11. Have more than one other family member participating in this study (NI-MC304); 12. Have at least 1 family member currently participating in a study, other than this study, with a berdazimer containing product (i.e. SB204, SB206, SB208, SB414); 13. Have participated in any other trial of an interventional investigational drug or device within 14 days or concurrent participation in another interventional research study; 14. 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 |
|---|---|---|
| A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | 12 Weeks | Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12. |
| 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 | 12 Weeks | Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12 |
| 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). |
| Change From Baseline in the Number of All Treatable MC at Week 4 | 4 Weeks | Percent change from Baseline in the number of all treatable MC at Week 4 |
Countries
United States
Participant flow
Pre-assignment details
Subjects receiving current treatment for MC at the time of the Screening Visit entered a wash out period of up to 14 days prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| SB206 10.3% Berdazimer SB206 10.3% berdazimer topically once daily
SB206 10.3% berdazimer: Topically once daily | 444 |
| Vehicle Gel Vehicle gel topically once daily
vehicle gel: Topically once daily | 447 |
| Total | 891 |
Baseline characteristics
| Characteristic | Total | Vehicle Gel | SB206 10.3% Berdazimer |
|---|---|---|---|
| Age, Customized 12 years old to <18 years old | 39 participants | 15 participants | 24 participants |
| Age, Customized 18 years old | 12 participants | 6 participants | 6 participants |
| Age, Customized 1 to <2 years old | 27 participants | 12 participants | 15 participants |
| Age, Customized <1 year old | 891 participants | 0 participants | 1 participants |
| Age, Customized 2 years old to <6 years old | 433 participants | 213 participants | 220 participants |
| Age, Customized 6 years old to <12 years old | 379 participants | 201 participants | 178 participants |
| Baseline number of Molluscum lesions | 21.8 Molluscum lesions STANDARD_DEVIATION 16.94 | 20.5 Molluscum lesions STANDARD_DEVIATION 16.18 | 23.1 Molluscum lesions STANDARD_DEVIATION 17.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 49 Participants | 28 Participants | 21 Participants |
| Race/Ethnicity, Customized Ethnicity Not Reported | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 181 Participants | 87 Participants | 94 Participants |
| Race/Ethnicity, Customized More than One Race | 26 Participants | 13 Participants | 13 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 6 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 702 Participants | 357 Participants | 345 Participants |
| Race/Ethnicity, Customized Race Not Reported | 25 Participants | 14 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 769 Participants | 382 Participants | 387 Participants |
| Region of Enrollment United States | 891 participants | 447 participants | 444 participants |
| Sex: Female, Male Female | 450 Participants | 234 Participants | 216 Participants |
| Sex: Female, Male Male | 441 Participants | 213 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 444 | 0 / 447 |
| other Total, other adverse events | 221 / 444 | 37 / 447 |
| serious Total, serious adverse events | 0 / 444 | 1 / 447 |
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 | 144 Participants |
| Placebo | Complete Clearance of All Treatable MC at Week 12 | 88 Participants |
Secondary
90% Reduction From Baseline in the Number of All Treatable MC at Week 12
Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
Time frame: 12 Weeks
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB206 | 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 | 191 Participants |
| Placebo | 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 | 107 Participants |
Secondary
A Lesion Count of 0 or 1 of All Treatable MC at Week 12
Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.
Time frame: 12 Weeks
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB206 | A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | 193 Participants |
| Placebo | A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | 110 Participants |
Secondary
Change From Baseline in the Number of All Treatable MC at Week 4
Percent change from Baseline in the number of all treatable MC at Week 4
Time frame: 4 Weeks
Population: ITT
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SB206 | Change From Baseline in the Number of All Treatable MC at Week 4 | -25.5 percentage of change from baseline | Standard Error 2.86 |
| Placebo | Change From Baseline in the Number of All Treatable MC at Week 4 | -9.2 percentage of change from baseline | Standard Error 2.86 |
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 | 87 Participants |
| Placebo | Complete Clearance of All Treatable MC at Week 8 | 52 Participants |