The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for 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
Results First Posted : January 20, 2023
Last Update Posted : March 23, 2023
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Novan, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Molluscum Contagiosum Drug: SB206 12% Drug: Placebo Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 13, 2019
Actual Primary Completion Date : November 11, 2019
Actual Study Completion Date : February 3, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SB206 12%
SB206 12% topically once daily
 Drug: SB206 12%
Topically once daily
Other Name: berdazimer sodium
Placebo Comparator: Placebo Comparator
Placebo topically once daily
 Drug: Placebo
Topically once daily
Other Name: Vehicle Gel


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complete Clearance of All Treatable MC 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).


Secondary Outcome Measures :
  1. Complete Clearance of All Treatable MC at Week 8 [ Time Frame: 8 Weeks ]
    Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927703


Locations
Show Show 27 study locations
Sponsors and Collaborators
Novan, Inc.
Synteract, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Adelaide Hebert, MD UTHealth McGovern Medical School, Houston
  Study Documents (Full-Text)

Documents provided by Novan, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] March 26, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT03927703    
Other Study ID Numbers: NI-MC302
First Posted: April 25, 2019    Key Record Dates
Results First Posted: January 20, 2023
Last Update Posted: March 23, 2023
Last Verified: March 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
 Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases