Molluscum ContagiosumPhase 3NCT03927716
A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
A Phase 3 study testing SB206 12% in people with Molluscum Contagiosum, run by Novan, Inc. at 35 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- SB206 12%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 35 sitesUnited States
- Study dates
- 3 Jun 2019to 29 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Site #183
Austin, Texas, 78759
Site #296
Beverly, Massachusetts, 01915
Site #287
Boca Raton, Florida, 33046
Site #302
Boise, Idaho, 83713
Site #259
Charleston, South Carolina, 29414
Site #280
Chicago, Illinois, 60611
Site #243
Clinton Township, Michigan, 48038
Site #270
Dublin, Ohio, 43016
Site #288
Evansville, Indiana, 47715
Site #295
Fountain Inn, South Carolina, 29644
Site #312
Glendale, Arizona, 85308
Site #279
Greensboro, North Carolina, 27408
Site #237
Gresham, Oregon, 97030
Site #251
Indianapolis, Indiana, 46250
Site #303
Jacksonville, Florida, 32256-6758
Site #269
Katy, Texas, 77494
Site #291
Kingsport, Tennessee, 37660
Site #298
Little Rock, Arkansas, 72212
Site #140
Lomita, California, 90717
Site #299
Longview, Texas, 75605
Site #117
Louisville, Kentucky, 40241
Site #285
Lynchburg, Virginia, 24501
Site #289
Metairie, Louisiana, 70006
Site #264
Miami, Florida, 33172
Site #286
Miami Lakes, Florida, 33014
Site #218
Mobile, Alabama, 36608
Site #219
Monroe, Louisiana, 71201
Site #116
Newnan, Georgia, 30263
Site #252
Norman, Oklahoma, 73071
Site #272
Rogers, Arkansas, 72758
Site #277
Salt Lake City, Utah, 84124
Site #224
San Antonio, Texas, 78218
Site #308
Silver Spring, Maryland, 20910
Site #311
Warwick, Rhode Island, 02886
Site #273
West Palm Beach, Florida, 33406
About this study
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
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.
Read the 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.
- Conditions
- Molluscum Contagiosum
- Being tested
- SB206 12%, Placebo
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB206 12%Drug
Also called berdazimer sodium
Topically once daily
PlaceboDrug
Also called Vehicle Gel
Topically once daily
| Study group | Role | What they receive |
|---|---|---|
| SB206 12% | Experimental | SB206 12% topically once daily Receives: Drug: SB206 12% |
| Placebo | Placebo comparator | Placebo topically once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Weeks
Secondary outcomes (1)
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).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start3 Jun 2019
- Primary completion28 Oct 2019
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927716
- Sponsor's protocol ID
- NI-MC301
- Status last verified
- Dec 2022
- First submitted
- 23 Apr 2019
- Last updated
- 27 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Maeda-Chubachi T, Hebert D, Messersmith E, Siegfried EC. SB206, a Nitric Oxide-Releasing Topical Medication, Induces the Beginning of the End Sign and Molluscum Clearance. JID Innov. 2021 May 5;1(3):100019. doi: 10.1016/j.xjidi.2021.100019. eCollection 2021 Sep.
PubMed 34909721
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03927716
- Acronym / sponsor ID
- NI-MC301
- Conditions
- Molluscum Contagiosum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Posted 27 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB206 12% | Experimental | Drug: SB206 12%SB206 12% topically once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo topically once daily |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB206 12%Also: berdazimer sodiumTopically once daily | Drug | SB206 12% |
| PlaceboAlso: Vehicle GelTopically once daily | Drug | Placebo |
Primary outcome
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).
1 secondary outcome
Complete Clearance of All Treatable MC at Week 8
Time frame: 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34909721Maeda-Chubachi T, Hebert D, Messersmith E, Siegfried EC. SB206, a Nitric Oxide-Releasing Topical Medication, Induces the Beginning of the End Sign and Molluscum Clearance. JID Innov. 2021 May 5;1(3):100019. doi: 10.1016/j.xjidi.2021.100019. eCollection 2021 Sep.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB206 12% in people with Molluscum Contagiosum, run by Novan, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance of All Treatable MC at Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.