CompletedNCT03436615Updated May 6, 2023Results posted

A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum

A Phase 2 interventional study of SB206 4% and SB206 8% in Molluscum Contagiosum, sponsored by Novan, Inc.. Completed at 18 sites in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Novan, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 256
Allocation: Randomized
Ages: 2 Years and older
Sex: All

Study summary

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

Read the detailed description

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in up to approximately 192 or 256 non-immunocompromised subjects with molluscum contagiosum. Subjects who satisfy entry criteria will be randomized 3:1 to ascending, sequential dose cohorts of SB206. The highest tolerated dose will also be run in a cohort once daily. Approximately 64 subjects will be randomized to each cohort. Subjects will be treated once daily, twice daily or three times a week for up to 12 weeks. After 30 subjects randomized in a cohort have completed 2 weeks of treatment, the Data Safety Monitoring Board (DSMB) will review the available unblinded safety and tolerability data. The DSMB will determine if the data supports escalating to the next highest dose for the next cohort or if the data shows the dose is not tolerable decreasing to the next lower dose or frequency for the next cohort.

Conditions studied

Molluscum Contagiosum

Browse trials for

Molluscum Contagiosum 22

In context

Molluscum Contagiosum

22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.

This study's enrollment of 256 is above the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.

Browse Molluscum Contagiosum studies →

Lead sponsor

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.

Browse Novan, Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

Be 2 years of age or older, and in good general health;
Have signed written form by a parent or legal guardian (assent form where required);
Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis;
Females 10 years of age and older must have a negative urine pregnancy test prior to randomization;
Females 10 years of age and older must agree to use an effective method of during the course of the study and for 30 days after their final study visit;
Be willing and able to follow study instructions and likely to complete all study requirements.

Exclusion criteria

Exclusion Criteria:

Are , have immunodeficiency disorder, or are on immunosuppressive treatment;
Have agminated MC that could make it difficult to provide accurate lesion counts;
Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions;
Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to count lesions;
Have received treatment with topical calcineurin inhibitors or 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 OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;
Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline;
Have MC only in periocular area;
Have MC only on the labia or penis;
Female subjects who are pregnant, planning a pregnancy or breastfeeding;
Have confirmed methemoglobin level of >3.0% at Baseline using a pulse co-oximeter;
Have know to any ingredients of SB206 or Vehicle Gel including ;
Have participated in a previous study with NVN1000;
Have participated in any other trial of an interventional drug or device within 30 days or concurrent participation in another interventional research study.

Terms in these criteria, in plain language(7)

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 256 participants (actual)

Study arms

Experimental
SB206 4%
SB206 4% topically twice daily
Drug: SB206 4%
Experimental
SB206 8%
SB206 8% topically twice daily
Drug: SB206 8%
Experimental
SB206 12%
SB206 12% topically once or twice daily
Drug: SB206 12%
Placebo comparator
Placebo (vehicle gel)
Vehicle Gel topically once or twice daily
Drug: Placebo

Interventions

DrugSB206 4%
Twice daily
Also known as: NVN1000
DrugSB206 8%
Twice daily
Also known as: NVN1000
DrugSB206 12%
Once or twice daily
Also known as: NVN1000
DrugPlacebo
Once or twice daily
Also known as: Vehicle Gel

What researchers measure

Primary outcomes

Proportion of Subjects Achieving Complete Clearance 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

Secondary outcomes

Proportion of Subjects Achieving Complete Clearance at Each Visit
Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
Time frame: Week 1; Week 2; Week 4; Week 8; Week 12
Time to First Complete Clearance
Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
Time frame: Week 12
Proportion of Subjects Achieving 75% Reduction at Each Visit
Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Mean Change in Molluscum Contagiosum at Each Visit
Mean change from baseline in number of molluscum contagiosum lesions at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Percent Change in Molluscum Contagiosum at Each Visit
Percent change from baseline in number of molluscum contagiosum lesions at each visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12

Results

Posted May 6, 2023

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Started	47	48	47	48	66
Completed	38	40	39	43	61
Not completed	9	8	8	5	5

Outcome measures

PrimaryProportion of Subjects Achieving Complete Clearance 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
Reported as:: Count of participants · Participants

Proportion of Subjects Achieving Complete Clearance at Week 12
Participants	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Proportion of Subjects Achieving Complete Clearance at Week 12	5	16	13	18	12

SecondaryProportion of Subjects Achieving Complete Clearance at Each Visit

Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.

Time frame:: Week 1; Week 2; Week 4; Week 8; Week 12
Reported as:: Number · participants

Proportion of Subjects Achieving Complete Clearance at Each Visit
participants	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Week 1 proportion of subjects achieving complete clearance.	0	1	0	1	0
Week 2 proportion of subjects achieving complete clearance.	1	1	1	3	1
Week 4 proportion of subjects achieving complete clearance.	1	3	3	5	2
Week 8 proportion of subjects achieving complete clearance.	3	7	10	11	6
Week 12 proportion of subjects achieving complete clearance.	5	16	13	18	12

SecondaryTime to First Complete Clearance

Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)

Time frame:: Week 12
Reported as:: Median · Days

Time to First Complete Clearance
Days	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Time to First Complete Clearance	NA (13 to 85)	100.0 (11 to 100)	91.0 (16 to 91)	85.0 (8 to 86)	93.0 (17 to 93)

SecondaryProportion of Subjects Achieving 75% Reduction at Each Visit

Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit

Time frame:: Week 1, Week 2, Week 4, Week 8, Week 12
Reported as:: Number · participants

Proportion of Subjects Achieving 75% Reduction at Each Visit
participants	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Week 1 proportion of subjects achieving complete clearance.	1	1	3	3	1
Week 2 proportion of subjects achieving complete clearance.	4	1	3	8	3
Week 4 proportion of subjects achieving complete clearance.	4	6	9	9	5
Week 8 proportion of subjects achieving complete clearance.	8	14	18	20	11
Week 12 proportion of subjects achieving complete clearance.	10	20	20	22	18

SecondaryMean Change in Molluscum Contagiosum at Each Visit

Mean change from baseline in number of molluscum contagiosum lesions at each visit

Time frame:: Week 1, Week 2, Week 4, Week 8, Week 12
Reported as:: Least squares mean · Molluscum lesion counts

Mean Change in Molluscum Contagiosum at Each Visit
Molluscum lesion counts	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Week 1	-1.5 ± 1.43	0 ± 1.33	-2.5 ± 1.44	-4.0 ± 1.27	0.7 ± 1.13
Week 2	-1.9 ± 1.53	-1.7 ± 1.45	-1.8 ± 1.57	-7.1 ± 1.41	-1.2 ± 1.23
Week 4	-1.8 ± 1.80	-6.0 ± 1.71	-6.2 ± 1.82	-8.7 ± 1.66	-0.9 ± 1.43
Week 8	-5.6 ± 2.08	-10.3 ± 2.00	-7.6 ± 2.10	-12.3 ± 1.92	-4.9 ± 1.65
Week 12	-7.2 ± 2.43	-12.0 ± 2.31	-9.9 ± 2.42	-12.9 ± 2.21	-8.6 ± 1.90

SecondaryPercent Change in Molluscum Contagiosum at Each Visit

Percent change from baseline in number of molluscum contagiosum lesions at each visit

Time frame:: Week 1, Week 2, Week 4, Week 8, Week 12
Reported as:: Least squares mean · Percentage change from baseline

Percent Change in Molluscum Contagiosum at Each Visit
Percentage change from baseline	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Week 1	0.0 ± 7.82	10.1 ± 7.33	-4.7 ± 7.84	-11.1 ± 6.96	8.7 ± 6.16
Week 2	-4.4 ± 8.44	5.8 ± 8.07	-5.9 ± 8.64	-29.2 ± 7.81	-4.1 ± 6.77
Week 4	-3.6 ± 8.19	-30.4 ± 7.75	-29.2 ± 8.32	-37.3 ± 7.54	-6.6 ± 6.51
Week 8	-19.2 ± 9.54	-47.5 ± 9.17	-38.7 ± 9.64	-56.3 ± 8.79	-17.2 ± 7.58
Week 12	-25.3 ± 9.65	-64.3 ± 9.07	-56.1 ± 9.61	-54.6 ± 8.70	-37.8 ± 7.54

Adverse events

Collected over Baseline visit to end of study visit, 85 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1: SB206 4% BID	0/46 (0%)	0/46 (0%)	7/46 (15.2%)
Cohort 2: SB206 8% BID	0/48 (0%)	0/48 (0%)	24/48 (50%)
Cohort 3: SB206 12% BID	0/47 (0%)	0/47 (0%)	18/47 (38.3%)
Cohort 4: SB206 12% QD	0/47 (0%)	0/47 (0%)	19/47 (40.4%)
Placebo (Vehicle Gel)	0/66 (0%)	0/66 (0%)	6/66 (9.1%)

Most frequent other events

Most frequent other events
Event	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)
Application site erythemaGeneral disorders	3/46	6/48	6/47	5/47	0/66
PyrexiaGeneral disorders	1/46	5/48	1/47	1/47	2/66
Application site painGeneral disorders	2/46	3/48	3/47	4/47	0/66
Application site exfoliationGeneral disorders	0/46	1/48	3/47	4/47	0/66
Application site pruritusGeneral disorders	1/46	1/48	4/47	2/47	0/66
DiarrhoeaGastrointestinal disorders	0/46	3/48	0/47	1/47	1/66
Pharyngitis streptococcalInfections and infestations	0/46	3/48	1/47	2/47	1/66
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/46	3/48	0/47	0/47	2/66

Baseline characteristics

ITT population

Age, Customized
Age, Customized(Participants)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
≥2 years of age	47	48	47	48	66	256

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
Female	22	27	22	25	27	123
Male	25	21	25	23	39	133

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
Hispanic or Latino	6	11	16	8	15	56
Not Hispanic or Latino	41	37	31	40	51	200
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
American Indian or Alaska Native	1	1	0	0	0	2
Asian	2	1	1	0	1	5
Native Hawaiian or Other Pacific Islander	0	0	1	0	0	1
Black or African American	1	3	0	2	1	7
White	40	42	44	44	58	228
More than one race	3	1	0	1	3	8
Unknown or Not Reported	0	0	1	1	3	5

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
United States	47	48	47	48	66	256

Baseline number of Molluscum lesions
Baseline number of Molluscum lesions(Molluscum lesions)	Cohort 1: SB206 4% BID	Cohort 2: SB206 8% BID	Cohort 3: SB206 12% BID	Cohort 4: SB206 12% QD	Placebo (Vehicle Gel)	Total
SB206	21.7 ± 17.23	19.0 ± 14.37	18.8 ± 16.15	17.6 ± 16.55	—	19.3 ± 16.05
Placebo (vehicle gel)	—	—	—	—	18.3 ± 14.47	18.3 ± 14.47

Study locations

18 sites

Premier Site# 266
Scottsdale, Arizona 85255, United States
Premier Site# 260
Santa Ana, California 92701, United States
Premier Site# 257
Thornton, Colorado 80233, United States
Premier Site# 264
Doral, Florida 33172, United States
Premier Site# 116
Newnan, Georgia 30263, United States
Premier Site# 251
Indianapolis, Indiana 46256, United States
Premier Site# 253
Lenexa, Kansas 66215, United States
Premier Site# 117
Louisville, Kentucky 40241, United States
Premier Site# 182
Las Vegas, Nevada 89129, United States
Premier Site# 252
Norman, Oklahoma 73071, United States
Premier Site# 237
Gresham, Oregon 97030, United States
Premier Site# 259
Charleston, South Carolina 29414, United States
Premier Site# 255
Mount Pleasant, South Carolina 29464, United States
Premier Site# 131
Houston, Texas 77004, United States
Premier Site# 167
Houston, Texas 77030, United States
Premier Site# 224
San Antonio, Texas 78218, United States
Premier Site# 256
Salt Lake City, Utah 84124, United States
Premier Site# 267
Richmond, Virginia 23294, United States

References and documents

Study documents

Study protocol ↗ · Jun 29, 2018
Statistical analysis plan ↗ · Aug 17, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Nov 2018, 9 months.

Results were first posted in May 2023, 4 years 6 months after primary completion. A results delay was requested in Sep 2019.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 6, 2018
First posted: Feb 19, 2018
StartActual: Jan 24, 2018
Primary completionActual: Nov 3, 2018
CompletionActual: Nov 3, 2018
Results delay requested: Sep 9, 2019
Results first posted: May 6, 2023
Last update: May 6, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03436615
Lead sponsor: Novan, Inc.
Collaborators: Premier Research Group plc
Responsible party: Sponsor
First posted: Feb 19, 2018
Start date: Jan 24, 2018
Primary completion: Nov 3, 2018
Completion: Nov 3, 2018
Results posted: May 6, 2023
Last update: May 6, 2023

Study contacts

Tomoko Maeda-Chubachi, MD

study chair · Novan, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Berdazimer sodium

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