Molluscum ContagiosumPhase 3B-SIMPLE4NCT04535531
A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
A Phase 3 study testing SB206 10.3% berdazimer in people with Molluscum Contagiosum, run by Novan, Inc. at 55 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 850 subjects 6 months of age and older with molluscum contagiosum (MC). 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 10.3% berdazimer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 891 participants
- Where
- 55 sitesUnited States
- Study dates
- 1 Sep 2020to 28 Jul 2021
- 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 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.
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), 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;
Show all 14Show 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 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.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Site #335
Apopka, Florida, 32703
Site #321
Baton Rouge, Louisiana, 70809
Site #201
Berlin, New Jersey, 08009
Site #342
Boca Raton, Florida, 33428
Site #328
Bowling Green, Kentucky, 42101
Site #346
Brighton, Massachusetts, 02135
Site #340
Chicago, Illinois, 60611
Site #274
Clarkston, Michigan, 48346
Site# 349
Covington, Louisiana, 70433
Site #288
Evansville, Indiana, 47715
Site #333
Fort Lauderdale, Florida, 33316
Site #295
Fountain Inn, South Carolina, 29644
Site #336
Fountain Valley, California, 92708
Site #329
Fremont, California, 94538
Site# 348
Fresno, California, 93711
Site #312
Glendale, Arizona, 85308
Site #279
Greensboro, North Carolina, 27408
Site #325
Greenwood Village, Colorado, 80111
Site #334
Homestead, Florida, 33030
Site #101
Hot Springs, Arkansas, 71913
Site #337
Houston, Texas, 77087
Site #291
Kingsport, Tennessee, 37660
Site #326
Knoxville, Tennessee, 37909
Site #281
Layton, Utah, 84041
Site #347
Lexington, Kentucky, 40517
Site #299
Longview, Texas, 75605
Site # 117
Louisville, Kentucky, 40241
Site #278
Miami, Florida, 33165
Site #314
Miami Lakes, Florida, 33014
Site #343
Morgantown, West Virginia, 26505
Site #316
Murfreesboro, Tennessee, 37130
Site #121
New Brighton, Minnesota, 55112
Site #332
New Orleans, Louisiana, 70119
Site #297
New Orleans, Louisiana, 70124
Site #116
Newnan, Georgia, 30263
Site #338
Omaha, Nebraska, 68114
Site #341
Orlando, Florida, 32829
Site #294
Owensboro, Kentucky, 42301
Site #310
Plainfield, Indiana, 46168
Site #250
Portland, Oregon, 97210
Site #267
Richmond, Virginia, 23294
Site #330
Rockville, Maryland, 20854
Site #272
Rogers, Arkansas, 72758
Site #253
Rolling Meadows, Illinois, 60008
Site #224
San Antonio, Texas, 78218
Site #161
San Diego, California, 92103
Site #227
Sanford, Florida, 32771
Site #339
Spokane, Washington, 99202
Site #265
Sugarloaf, Pennsylvania, 18249
Site #255
Summerville, South Carolina, 29486
Site #305
Tampa, Florida, 33163
Site #327
Thousand Oaks, California, 91320
Site #331
Verona, New Jersey, 07044
Site #311
Warwick, Rhode Island, 02866
Site #345
West Jordan, Utah, 84088
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 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.
Read the 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.
- Conditions
- Molluscum Contagiosum
- Being tested
- SB206 10.3% berdazimer, vehicle gel
- 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 10.3% berdazimerDrug
Also called SB206 12% berdazimer sodium
Topically once daily
vehicle gelDrug
Topically once daily
| Study group | Role | What they receive |
|---|---|---|
| SB206 10.3% berdazimer | Experimental | SB206 10.3% berdazimer topically once daily Receives: Drug: SB206 10.3% berdazimer |
| vehicle gel | Placebo comparator | Vehicle gel topically once daily Receives: Drug: vehicle gel |
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 (4)
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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Sep 2020
- Primary completion28 Apr 2021
- Study completion28 Jul 2021
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 (2)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
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc., Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- Tomoko Maeda Chubachi, MD PhD, Study director, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535531
- Sponsor's protocol ID
- NI-MC304
- Acronym
- B-SIMPLE4
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2020
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Browning JC, Cartwright M, Thorla I Jr, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. Am J Clin Dermatol. 2023 Jan;24(1):119-133. doi: 10.1007/s40257-022-00733-9. Epub 2022 Oct 26.
PubMed 36287306Browning JC, Enloe C, Cartwright M, Hebert A, Paller AS, Hebert D, Kowalewski EK, Maeda-Chubachi T. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721.
PubMed 35830173
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. 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
- NCT04535531
- Acronym / sponsor ID
- B-SIMPLE4 / NI-MC304
- Conditions
- Molluscum Contagiosum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc., Synteract, Inc.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 26 Jan 2023
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB206 10.3% berdazimer | Experimental | Drug: SB206 10.3% berdazimerSB206 10.3% berdazimer topically once daily |
| vehicle gel | Placebo comparator | Drug: vehicle gelVehicle gel 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 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;
Key exclusion criteria (14 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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies);
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 10.3% berdazimerAlso: SB206 12% berdazimer sodiumTopically once daily | Drug | SB206 10.3% berdazimer |
| vehicle gelTopically once daily | Drug | vehicle gel |
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).
4 secondary outcomes
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
Time frame: 12 Weeks
Complete Clearance of All Treatable MC at Week 8
Time frame: 8 Weeks
Change From Baseline in the Number of All Treatable MC at Week 4
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36287306Browning JC, Cartwright M, Thorla I Jr, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. Am J Clin Dermatol. 2023 Jan;24(1):119-133. doi: 10.1007/s40257-022-00733-9. Epub 2022 Oct 26.
- Derived from this study: PubMed 35830173Browning JC, Enloe C, Cartwright M, Hebert A, Paller AS, Hebert D, Kowalewski EK, Maeda-Chubachi T. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721.
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.
Tomoko Maeda Chubachi, MD PhD study director
Novan, Inc.
55 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 10.3% berdazimer in people with Molluscum Contagiosum, run by Novan, Inc. at 55 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 14 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 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 26 Jan 2023). 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 NCT04535531, which also lists 2 linked publications.
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 26 Jan 2023.