A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)
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| ClinicalTrials.gov Identifier: NCT04535531 |
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Recruitment Status :
Completed
First Posted : September 2, 2020
Results First Posted : January 26, 2023
Last Update Posted : January 26, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Molluscum Contagiosum | Drug: SB206 10.3% berdazimer Drug: vehicle gel | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 891 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy and Safety of SB206 and Vehicle Gel Once Daily in the Treatment of Molluscum Contagiosum |
| Actual Study Start Date : | September 1, 2020 |
| Actual Primary Completion Date : | April 28, 2021 |
| Actual Study Completion Date : | July 28, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SB206 10.3% berdazimer
SB206 10.3% berdazimer topically once daily
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Drug: SB206 10.3% berdazimer
Topically once daily
Other Name: SB206 12% berdazimer sodium |
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Placebo Comparator: vehicle gel
Vehicle gel topically once daily
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Drug: vehicle gel
Topically once daily |
- Complete Clearance of All Treatable MC at Week 12 [ Time Frame: 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).
- A Lesion Count of 0 or 1 of All Treatable MC at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 Weeks ]Percent change from Baseline in the number of all treatable MC at Week 4
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be 6 months of age or older, and in good general health;
- Have a documented 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 lesions at Baseline;
- 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.
- Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera;
- Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.
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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies);
- Have received surgical procedures related to MC (e.g. cryotherapy, curettage) 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 containing product (i.e. SB204, SB206, SB208, SB414);
- Have more than one other family member participating in this study (NI-MC304);
- 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);
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535531
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| Study Director: | Tomoko Maeda Chubachi, MD PhD | Novan, Inc. |
Documents provided by Novan, Inc.:
| Responsible Party: | Novan, Inc. |
| ClinicalTrials.gov Identifier: | NCT04535531 |
| Other Study ID Numbers: |
NI-MC304 |
| First Posted: | September 2, 2020 Key Record Dates |
| Results First Posted: | January 26, 2023 |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | November 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Molluscum Contagiosum Poxviridae Infections DNA Virus Infections Virus Diseases |
Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |