- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436615
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
256
Phase
- 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
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Arizona
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Scottsdale, Arizona, United States, 85255
- Premier Site# 266
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California
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Santa Ana, California, United States, 92701
- Premier Site# 260
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Colorado
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Thornton, Colorado, United States, 80233
- Premier Site# 257
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Florida
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Doral, Florida, United States, 33172
- Premier Site# 264
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Georgia
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Newnan, Georgia, United States, 30263
- Premier Site# 116
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Indiana
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Indianapolis, Indiana, United States, 46256
- Premier Site# 251
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Kansas
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Lenexa, Kansas, United States, 66215
- Premier Site# 253
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Kentucky
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Louisville, Kentucky, United States, 40241
- Premier Site# 117
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Nevada
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Las Vegas, Nevada, United States, 89129
- Premier Site# 182
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Oklahoma
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Norman, Oklahoma, United States, 73071
- Premier Site# 252
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Oregon
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Gresham, Oregon, United States, 97030
- Premier Site# 237
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South Carolina
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Charleston, South Carolina, United States, 29414
- Premier Site# 259
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Mount Pleasant, South Carolina, United States, 29464
- Premier Site# 255
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Texas
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Houston, Texas, United States, 77004
- Premier Site# 131
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Houston, Texas, United States, 77030
- Premier Site# 167
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San Antonio, Texas, United States, 78218
- Premier Site# 224
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Utah
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Salt Lake City, Utah, United States, 84124
- Premier Site# 256
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Virginia
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Richmond, Virginia, United States, 23294
- Premier Site# 267
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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
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 |
Intervention / Treatment |
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Experimental: SB206 4%
SB206 4% topically twice daily
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Twice daily
Other Names:
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Experimental: SB206 8%
SB206 8% topically twice daily
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Twice daily
Other Names:
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Experimental: SB206 12%
SB206 12% topically once or twice daily
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Once or twice daily
Other Names:
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Placebo Comparator: Placebo (vehicle gel)
Vehicle Gel topically once or twice daily
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Once or twice daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Achieving Complete Clearance at Week 12
Time Frame: 12 weeks
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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).
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12 weeks
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Secondary Outcome Measures
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
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Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
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Week 1; Week 2; Week 4; Week 8; Week 12
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Time to First Complete Clearance
Time Frame: Week 12
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Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
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Week 12
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Proportion of Subjects Achieving 75% Reduction at Each Visit
Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12
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Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit
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Week 1, Week 2, Week 4, Week 8, Week 12
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Mean Change in Molluscum Contagiosum at Each Visit
Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12
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Mean change from baseline in number of molluscum contagiosum lesions at each visit
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Week 1, Week 2, Week 4, Week 8, Week 12
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Percent Change in Molluscum Contagiosum at Each Visit
Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12
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Percent change from baseline in number of molluscum contagiosum lesions at each visit
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Week 1, Week 2, Week 4, Week 8, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
January 24, 2018
Primary Completion (Actual)
November 3, 2018
Study Completion (Actual)
November 3, 2018
Study Registration Dates
First Submitted
February 6, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Molluscum Contagiosum
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University of North Carolina, Chapel HillNational Center for Research Resources (NCRR); Doris Duke Charitable FoundationCompleted
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Medical University of South CarolinaThe Skin Center Dermatology GroupCompletedVerruca Vulgaris | Molluscum Contagiosum Skin InfectionUnited States
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Center for Clinical Studies, TexasLEO PharmaWithdrawnMolluscum ContagiosumUnited States
-
Verrica Pharmaceuticals Inc.Paidion Research, Inc.; Instat Consulting, Inc.; Database Integrations, Inc.Completed
-
Steven R CohenCompletedMolluscum ContagiosumUnited States
-
Montefiore Medical CenterCompleted
-
Combined Military Hospital AbbottabadCompletedComparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum ContagiosumMolluscum ContagiosumPakistan
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Combined Military Hospital AbbottabadCompletedMolluscum ContagiosumPakistan
Clinical Trials on SB206 4%
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Novan, Inc.Synteract, Inc.; Therapeutics, Inc.CompletedMolluscum ContagiosumUnited States
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
-
Novan, Inc.PPDCompletedGenital Warts | Perianal WartsUnited States
-
Pharma Holdings ASCTC Clinical Trial Consultants ABCompletedNasal Decolonization of Staphylococcus AureusSweden
-
Janssen Research & Development, LLCCompleted
-
Maisonneuve-Rosemont HospitalCompleted
-
Jeffrey A. Cohen, MDJacobus PharmaceuticalTerminatedMuscle WeaknessUnited States
-
University of UtahNovartisWithdrawnEndometrial CancerUnited States
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompleted