A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)

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

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.

Study Overview

• Status: Completed
• Conditions: Molluscum Contagiosum
• Intervention / Treatment: Drug: SB206 12%; Drug: Placebo

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: Interventional
• Enrollment (Actual): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Site #218
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Site #312
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Site #298
    • Rogers, Arkansas, United States, 72758
      • Site #272
  • California
    • Lomita, California, United States, 90717
      • Site #140
  • Florida
    • Boca Raton, Florida, United States, 33046
      • Site #287
    • Jacksonville, Florida, United States, 32256-6758
      • Site #303
    • Miami, Florida, United States, 33172
      • Site #264
    • Miami Lakes, Florida, United States, 33014
      • Site #286
    • West Palm Beach, Florida, United States, 33406
      • Site #273
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Site #116
  • Idaho
    • Boise, Idaho, United States, 83713
      • Site #302
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Site #280
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Site #288
    • Indianapolis, Indiana, United States, 46250
      • Site #251
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Site #117
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Site #289
    • Monroe, Louisiana, United States, 71201
      • Site #219
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Site #308
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Site #296
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Site #243
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Site #279
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Site #270
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Site #252
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Site #237
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Site #311
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Site #259
    • Fountain Inn, South Carolina, United States, 29644
      • Site #295
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Site #291
  • Texas
    • Austin, Texas, United States, 78759
      • Site #183
    • Katy, Texas, United States, 77494
      • Site #269
    • Longview, Texas, United States, 75605
      • Site #299
    • San Antonio, Texas, United States, 78218
      • Site #224
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Site #277
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Site #285

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB206 12%; SB206 12% topically once daily	Drug: SB206 12%; Topically once daily; Other Names: berdazimer sodium
Placebo Comparator: Placebo; Placebo topically once daily	Drug: Placebo; Topically once daily; Other Names: Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Clearance of All Treatable MC at Week 12	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

Outcome Measure	Measure Description	Time Frame
Complete Clearance of All Treatable MC at Week 8	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).	8 Weeks

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: Synteract, Inc.

Publications and helpful links

General Publications

• Maeda-Chubachi T, Hebert D, Messersmith E, Siegfried EC. SB206, a Nitric Oxide-Releasing Topical Medication, Induces the Beginning of the End Sign and Molluscum Clearance. JID Innov. 2021 May 5;1(3):100019. doi: 10.1016/j.xjidi.2021.100019. eCollection 2021 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Poxviridae Infections; Molluscum Contagiosum
• Other Study ID Numbers: NI-MC301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No