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A Phase 3 Randomized, Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927703
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE June 5, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Complete clearance of all treatable MC at Week 12 [ Time Frame: 12 Weeks ]
Proportion of subjects with complete clearance of all treatable MC at Week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Complete clearance of all treatable MC at Week 8 [ Time Frame: 8 Weeks ]
Proportion of subjects with complete clearance of all treatable MC at Week 8
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Randomized, Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE2)
Official Title  ICMJE 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
Brief Summary This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% 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 approximately 340 subjects with MC. After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 2:1 (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 SB206 12% 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. Subjects or their caregivers will continue to treat the area until the next scheduled visit even if the lesion(s) clear. If the investigator determines all lesions are cleared at a clinic visit, the treatment may stop. Subjects will visit the clinic at Screening/Baseline, Week 2, Week 4, Week 8, Week 12. In addition, subjects will be seen in the clinic for a safety follow-up at Week 24.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Molluscum Contagiosum
Intervention  ICMJE
  • Drug: SB206 12%
    Topically once daily
    Other Name: berdazimer sodium
  • Drug: Placebo
    Topically once daily
    Other Name: Vehicle Gel
Study Arms  ICMJE
  • Experimental: SB206 12%
    SB206 12% topically once daily
    Intervention: Drug: SB206 12%
  • Placebo Comparator: Placebo Comparator
    Placebo topically once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2020)
355
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
340
Actual Study Completion Date  ICMJE February 3, 2020
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be 6 months of age or older, and in good general health;
  • Have a written 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 at Baseline;
  • Female subjects age 9 and above must have a negative UPT at Baseline;
  • Female subjects age 9 and above must agree to practice a medically acceptable form of birth control during the study and for 30 days after Week 12/ET1;
  • Be willing and able to follow study instructions and likely to complete all study requirements.

Exclusion Criteria:

  • 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);
  • Have received surgical procedures related to MC (cryotherapy, curettage, other) within 14 days prior to Baseline;
  • 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 sodium product (SB204, SB206, SB208, SB414);
  • Have more than 1 family member currently participating in a study with a berdazimer sodium product (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927703
Other Study ID Numbers  ICMJE NI-MC302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novan, Inc.
Study Sponsor  ICMJE Novan, Inc.
Collaborators  ICMJE Synteract, Inc.
Investigators  ICMJE
Principal Investigator: Adelaide Hebert, MD UTHealth McGovern Medical School, Houston
PRS Account Novan, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP