A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)

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 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% 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 10.3% berdazimer; Drug: vehicle gel

Detailed Description

This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (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 treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24.

• Study Type: Interventional
• Enrollment (Actual): 891
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Site #312
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Site #101
    • Rogers, Arkansas, United States, 72758
      • Site #272
  • California
    • Fountain Valley, California, United States, 92708
      • Site #336
    • Fremont, California, United States, 94538
      • Site #329
    • Fresno, California, United States, 93711
      • Site# 348
    • San Diego, California, United States, 92103
      • Site #161
    • Thousand Oaks, California, United States, 91320
      • Site #327
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Site #325
  • Florida
    • Apopka, Florida, United States, 32703
      • Site #335
    • Boca Raton, Florida, United States, 33428
      • Site #342
    • Fort Lauderdale, Florida, United States, 33316
      • Site #333
    • Homestead, Florida, United States, 33030
      • Site #334
    • Miami, Florida, United States, 33165
      • Site #278
    • Miami Lakes, Florida, United States, 33014
      • Site #314
    • Orlando, Florida, United States, 32829
      • Site #341
    • Sanford, Florida, United States, 32771
      • Site #227
    • Tampa, Florida, United States, 33163
      • Site #305
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Site #116
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Site #340
    • Rolling Meadows, Illinois, United States, 60008
      • Site #253
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Site #288
    • Plainfield, Indiana, United States, 46168
      • Site #310
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Site #328
    • Lexington, Kentucky, United States, 40517
      • Site #347
    • Louisville, Kentucky, United States, 40241
      • Site # 117
    • Owensboro, Kentucky, United States, 42301
      • Site #294
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Site #321
    • Covington, Louisiana, United States, 70433
      • Site# 349
    • New Orleans, Louisiana, United States, 70119
      • Site #332
    • New Orleans, Louisiana, United States, 70124
      • Site #297
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Site #330
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Site #346
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Site #274
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Site #121
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Site #338
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Site #201
    • Verona, New Jersey, United States, 07044
      • Site #331
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Site #279
  • Oregon
    • Portland, Oregon, United States, 97210
      • Site #250
  • Pennsylvania
    • Sugarloaf, Pennsylvania, United States, 18249
      • Site #265
  • Rhode Island
    • Warwick, Rhode Island, United States, 02866
      • Site #311
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644
      • Site #295
    • Summerville, South Carolina, United States, 29486
      • Site #255
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Site #291
    • Knoxville, Tennessee, United States, 37909
      • Site #326
    • Murfreesboro, Tennessee, United States, 37130
      • Site #316
  • Texas
    • Houston, Texas, United States, 77087
      • Site #337
    • Longview, Texas, United States, 75605
      • Site #299
    • San Antonio, Texas, United States, 78218
      • Site #224
  • Utah
    • Layton, Utah, United States, 84041
      • Site #281
    • West Jordan, Utah, United States, 84088
      • Site #345
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Site #267
  • Washington
    • Spokane, Washington, United States, 99202
      • Site #339
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Site #343

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:

1. Be 6 months of age or older, and in good general health;
2. Have a documented informed consent form signed by subject or a parent or legal guardian and an assent form as required;
3. Have between 3 and 70 treatable MC lesions at Baseline;
4. For women of childbearing potential (WOCBP): Must have a negative urine pregnancy test prior to randomization and must agree to use an effective method of birth control during the study; Note: WOCBP and effective methods of birth control are outlined in Section 9.4.
5. Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera;
6. Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.

Exclusion Criteria:

1. Have strongly suggested sexually transmitted MC and do not agree to refrain from sexual activities throughout the study period;
2. Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;
3. Have significant injury on and/or surrounding MC that may impact ability to treat and count lesions;
4. Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to Baseline;
5. 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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies);
6. Have received surgical procedures related to MC (e.g. cryotherapy, curettage) within 14 days prior to Baseline;
7. Have MC only in periocular area;
8. Female subjects who are pregnant, planning a pregnancy or breastfeeding;
9. Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;
10. Have participated in a previous study with a berdazimer containing product (i.e. SB204, SB206, SB208, SB414);
11. Have more than one other family member participating in this study (NI-MC304);
12. Have at least 1 family member currently participating in a study, other than this study, with a berdazimer containing product (i.e. SB204, SB206, SB208, SB414);
13. Have participated in any other trial of an interventional investigational drug or device within 14 days or concurrent participation in another interventional research study;
14. 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 10.3% berdazimer; SB206 10.3% berdazimer topically once daily	Drug: SB206 10.3% berdazimer; Topically once daily; Other Names: SB206 12% berdazimer sodium
Placebo Comparator: vehicle gel; Vehicle gel topically once daily	Drug: vehicle gel; Topically once daily

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
A Lesion Count of 0 or 1 of All Treatable MC at Week 12	Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.	12 Weeks
90% Reduction From Baseline in the Number of All Treatable MC at Week 12	Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12	12 Weeks
Change From Baseline in the Number of All Treatable MC at Week 4	Percent change from Baseline in the number of all treatable MC at Week 4	4 Weeks

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: Synteract, Inc.; Therapeutics, Inc.
• Investigators: Study Director: Tomoko Maeda Chubachi, MD PhD, Novan, Inc.

Publications and helpful links

General Publications

• Browning JC, Cartwright M, Thorla I Jr, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. Am J Clin Dermatol. 2022 Oct 26. doi: 10.1007/s40257-022-00733-9. Online ahead of print.
• Browning JC, Enloe C, Cartwright M, Hebert A, Paller AS, Hebert D, Kowalewski EK, Maeda-Chubachi T. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: November 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-MC304

Drug and device information, study documents

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