A Phase 3 interventional study of SB206 10.3% berdazimer and vehicle gel in Molluscum Contagiosum, sponsored by Novan, Inc.. Completed at 55 sites in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Novan, Inc. · Phase 3, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.
This study's enrollment of 891 is above the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.
Browse Molluscum Contagiosum studies →Novan, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SB206 10.3% berdazimer topically once daily
Drug: SB206 10.3% berdazimer
Vehicle gel topically once daily
Drug: vehicle gel
Topically once daily
Also known as: SB206 12% berdazimer sodium
Topically once daily
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
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
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
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
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
| Milestone | SB206 10.3% Berdazimer | Vehicle Gel |
|---|---|---|
| Started | 444 | 447 |
| Completed | 363 | 390 |
| Not completed | 81 | 57 |
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).
| Participants | SB206 | Placebo |
|---|---|---|
| Complete Clearance of All Treatable MC at Week 12 | 144 | 88 |
Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.
| Participants | SB206 | Placebo |
|---|---|---|
| A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | 193 | 110 |
Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
| Participants | SB206 | Placebo |
|---|---|---|
| 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 | 191 | 107 |
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).
| Participants | SB206 | Placebo |
|---|---|---|
| Complete Clearance of All Treatable MC at Week 8 | 87 | 52 |
Percent change from Baseline in the number of all treatable MC at Week 4
| percentage of change from baseline | SB206 | Placebo |
|---|---|---|
| Change From Baseline in the Number of All Treatable MC at Week 4 | -25.5 ± 2.86 | -9.2 ± 2.86 |
Collected over Baseline visit to end of study visit, 84 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB206 | 0/444 (0%) | 0/444 (0%) | 221/444 (49.8%) |
| Placebo | 0/447 (0%) | 1/447 (0.2%) | 37/447 (8.3%) |
| Event | SB206 | Placebo |
|---|---|---|
| Supracondylar Fracture of right humerus, closed reductionInjury, poisoning and procedural complications | 0/444 | 1/447 |
| Event | SB206 | Placebo |
|---|---|---|
| Application site painGeneral disorders | 83/444 | 23/447 |
| Application site erythemaGeneral disorders | 52/444 | 6/447 |
| Application site pruritusGeneral disorders | 33/444 | 5/447 |
| Application site exfoliationGeneral disorders | 27/444 | 0/447 |
| Application site dermatitisGeneral disorders | 26/444 | 3/447 |
| Age, Customized(participants) | SB206 10.3% Berdazimer | Vehicle Gel | Total |
|---|---|---|---|
| <1 year old | 1 | 0 | 891 |
| 1 to <2 years old | 15 | 12 | 27 |
| 2 years old to <6 years old | 220 | 213 | 433 |
| 6 years old to <12 years old | 178 | 201 | 379 |
| 12 years old to <18 years old | 24 | 15 | 39 |
| 18 years old | 6 | 6 | 12 |
| Sex: Female, Male(Participants) | SB206 10.3% Berdazimer | Vehicle Gel | Total |
|---|---|---|---|
| Female | 216 | 234 | 450 |
| Male | 228 | 213 | 441 |
| Race/Ethnicity, Customized(Participants) | SB206 10.3% Berdazimer | Vehicle Gel | Total |
|---|---|---|---|
| Hispanic or Latino | 94 | 87 | 181 |
| Not Hispanic or Latino | 345 | 357 | 702 |
| Ethnicity Not Reported | 4 | 1 | 5 |
| Unknown | 1 | 2 | 3 |
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 6 | 6 | 12 |
| Black or African American | 21 | 28 | 49 |
| Native Hawaiian or Other Pacific Islander | 4 | 2 | 6 |
| White | 387 | 382 | 769 |
| More than One Race | 13 | 13 | 26 |
| Race Not Reported | 11 | 14 | 25 |
| Region of Enrollment(participants) | SB206 10.3% Berdazimer | Vehicle Gel | Total |
|---|---|---|---|
| United States | 444 | 447 | 891 |
| Baseline number of Molluscum lesions(Molluscum lesions) | SB206 10.3% Berdazimer | Vehicle Gel | Total |
|---|---|---|---|
| Mean | 23.1 ± 17.60 | 20.5 ± 16.18 | 21.8 ± 16.94 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2020 to primary completion in Apr 2021, 7 months.
Results were first posted in Jan 2023, 1 year 8 months after primary completion.
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berdazimer sodium