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Trial record 1 of 4 for:    SB206
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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-SIMPLE1)

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ClinicalTrials.gov Identifier: NCT03927716
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Novan, Inc.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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

Placebo Comparator: Placebo
Placebo topically once daily
Drug: Placebo
Topically once daily
Other Name: Vehicle Gel




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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.

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): NCT03927716


Contacts
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Contact: Teresa Reams 919-485-8080 treams@novan.com

Locations
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United States, Illinois
Site #280 Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Kentucky
Site #117 Not yet recruiting
Louisville, Kentucky, United States, 40241
United States, Nevada
Site #182 Not yet recruiting
Las Vegas, Nevada, United States, 89148
United States, Texas
Site #183 Not yet recruiting
Austin, Texas, United States, 78759
Sponsors and Collaborators
Novan, Inc.
Synteract, Inc.
Investigators
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Principal Investigator: Amy Paller, MD Northwestern University

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Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT03927716     History of Changes
Other Study ID Numbers: NI-MC301
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases