Molluscum ContagiosumPhase 2NCT03436615

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

A Phase 2 study testing SB206 4%, SB206 8% and SB206 12% in people with Molluscum Contagiosum, run by Novan, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Molluscum Contagiosum
What is being tested?: SB206 4%, SB206 8% and SB206 12%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 256 participants
Where: 18 sitesUnited States
Study dates: 24 Jan 2018to 3 Nov 2018
Phase: Phase 2
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 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Be 2 years of age or older, and in good general health;
Have signed written informed consent 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 birth control 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.

Who cannot join

Are immunosuppressed, 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 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 OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;

Show all 14Show fewer

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 hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;
Have participated in a previous study with NVN1000;
Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

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

Other trials in United States

About this study

Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Ascending Dose Study of SB206 in Subjects With Molluscum Contagiosum

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: Molluscum Contagiosum
Being tested: SB206 4%, SB206 8%, 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 4%Drug
Also called NVN1000
Twice daily
SB206 8%Drug
Also called NVN1000
Twice daily
SB206 12%Drug
Also called NVN1000
Once or twice daily
PlaceboDrug
Also called Vehicle Gel
Once or twice daily

Study groups in NCT03436615
Study group	Role	What they receive
SB206 4%	Experimental	SB206 4% topically twice daily Receives: Drug: SB206 4%
SB206 8%	Experimental	SB206 8% topically twice daily Receives: Drug: SB206 8%
SB206 12%	Experimental	SB206 12% topically once or twice daily Receives: Drug: SB206 12%
Placebo (vehicle gel)	Placebo comparator	Vehicle Gel topically once or twice daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 weeks

Secondary outcomes (5)

Proportion of Subjects Achieving Complete Clearance at Each Visit
Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Week 1, Week 2, Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20183 Nov 2018

First posted19 Feb 2018
Study start24 Jan 2018
Primary completion3 Nov 2018
Study completion3 Nov 2018

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03436615
Sponsor's protocol ID: NI-MC201
Status last verified: Apr 2023
First submitted: 6 Feb 2018
Last updated: 6 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Ascending Dose Study of SB206 in Subjects With Molluscum Contagiosum
ClinicalTrials.gov ID: NCT03436615
Acronym / sponsor ID: NI-MC201
Conditions: Molluscum Contagiosum
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Novan, Inc.Industry (pharma, biotech, devices)
Collaborators: Premier Research
Study start: 24 Jan 2018 (actual)
Primary completion: 3 Nov 2018 (actual)
Study completion: 3 Nov 2018 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 6 May 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 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 4

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

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Be 2 years of age or older, and in good general health;
Have signed written informed consent 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 birth control during the course of the study and for 30 days after their final study visit;

Key exclusion criteria (14 listed)

Are immunosuppressed, 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 steroids on MC or within 2 cm of MC lesions within 14 days prior to baseline;

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 4%Also: NVN1000Twice daily	Drug	SB206 4%
SB206 8%Also: NVN1000Twice daily	Drug	SB206 8%
SB206 12%Also: NVN1000Once or twice daily	Drug	SB206 12%
PlaceboAlso: Vehicle GelOnce or twice daily	Drug	Placebo (vehicle gel)

Primary outcome

Proportion of Subjects Achieving Complete Clearance 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).

5 secondary outcomes

Proportion of Subjects Achieving Complete Clearance at Each Visit
Time frame: Week 1; Week 2; Week 4; Week 8; Week 12
Time to First Complete Clearance
Time frame: Week 12
Proportion of Subjects Achieving 75% Reduction at Each Visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Mean Change in Molluscum Contagiosum at Each Visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12
Percent Change in Molluscum Contagiosum at Each Visit
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12

Results and safety

Results posted to the registry on 6 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: SB206 4% BID	47	38
Cohort 2: SB206 8% BID	48	40
Cohort 3: SB206 12% BID	47	39
Cohort 4: SB206 12% QD	48	43
Placebo (Vehicle Gel)	66	61

Primary outcome: Proportion of Subjects Achieving Complete Clearance at Week 12

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Cohort 1: SB206 4% BID n = 38	Cohort 2: SB206 8% BID n = 39	Cohort 3: SB206 12% BID n = 37	Cohort 4: SB206 12% QD n = 43	Placebo (Vehicle Gel) n = 60
Value	5	16	13	18	12

Population analysed: mITT Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline visit to end of study visit, 85 days.. Other adverse events reported at 5% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 study chair

Novan, Inc.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB206 4%, SB206 8% and SB206 12% in people with Molluscum Contagiosum, run by Novan, Inc. at 18 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 May 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?

Proportion of Subjects Achieving Complete Clearance 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 NCT03436615.

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 6 May 2023.