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

April 10, 2023 updated by: Novan, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SB206 4%
SB206 4% topically twice daily
Drug: SB206 4%
Twice daily
Other Names:
  • NVN1000
Experimental: SB206 8%
SB206 8% topically twice daily
Drug: SB206 8%
Twice daily
Other Names:
  • NVN1000
Experimental: SB206 12%
SB206 12% topically once or twice daily
Drug: SB206 12%
Once or twice daily
Other Names:
  • NVN1000
Placebo Comparator: Placebo (vehicle gel)
Vehicle Gel topically once or twice daily
Drug: Placebo
Once or twice daily
Other Names:
  • Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving Complete Clearance at Each Visit
Time Frame: Week 1; Week 2; Week 4; Week 8; Week 12
Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
Week 1; Week 2; Week 4; Week 8; Week 12
Time to First Complete Clearance
Time Frame: Week 12
Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
Week 12
Proportion of Subjects Achieving 75% Reduction at Each Visit
Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12
Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit
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
Mean change from baseline in number of molluscum contagiosum lesions at each visit
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
Percent change from baseline in number of molluscum contagiosum lesions at each visit
Week 1, Week 2, Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novan, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Premier Research Group plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI-MC201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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