A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

NCT ID: NCT04535531

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 891 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-07-28

Brief Summary

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.

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.

Conditions

Molluscum Contagiosum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SB206 10.3% berdazimer

SB206 10.3% berdazimer topically once daily

Group Type: EXPERIMENTAL

SB206 10.3% berdazimer

Intervention Type: DRUG

Topically once daily

vehicle gel

Vehicle gel topically once daily

Group Type: PLACEBO_COMPARATOR

vehicle gel

Intervention Type: DRUG

Topically once daily

Interventions

SB206 10.3% berdazimer

Topically once daily

Intervention Type: DRUG

vehicle gel

Topically once daily

Intervention Type: DRUG

Other Intervention Names

SB206 12% berdazimer sodium

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Synteract, Inc.

INDUSTRY

Sponsor Role: collaborator

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomoko Maeda Chubachi, MD PhD

Role: STUDY_DIRECTOR

Novan, Inc.

Locations

Site #312

Glendale, Arizona, United States

Site #101

Hot Springs, Arkansas, United States

Site #272

Rogers, Arkansas, United States

Site #336

Fountain Valley, California, United States

Site #329

Fremont, California, United States

Site# 348

Fresno, California, United States

Site #161

San Diego, California, United States

Site #327

Thousand Oaks, California, United States

Site #325

Greenwood Village, Colorado, United States

Site #335

Apopka, Florida, United States

Site #342

Boca Raton, Florida, United States

Site #333

Fort Lauderdale, Florida, United States

Site #334

Homestead, Florida, United States

Site #278

Miami, Florida, United States

Site #314

Miami Lakes, Florida, United States

Site #341

Orlando, Florida, United States

Site #227

Sanford, Florida, United States

Site #305

Tampa, Florida, United States

Site #116

Newnan, Georgia, United States

Site #340

Chicago, Illinois, United States

Site #253

Rolling Meadows, Illinois, United States

Site #288

Evansville, Indiana, United States

Site #310

Plainfield, Indiana, United States

Site #328

Bowling Green, Kentucky, United States

Site #347

Lexington, Kentucky, United States

Site # 117

Louisville, Kentucky, United States

Site #294

Owensboro, Kentucky, United States

Site #321

Baton Rouge, Louisiana, United States

Site# 349

Covington, Louisiana, United States

Site #332

New Orleans, Louisiana, United States

Site #297

New Orleans, Louisiana, United States

Site #330

Rockville, Maryland, United States

Site #346

Brighton, Massachusetts, United States

Site #274

Clarkston, Michigan, United States

Site #121

New Brighton, Minnesota, United States

Site #338

Omaha, Nebraska, United States

Site #201

Berlin, New Jersey, United States

Site #331

Verona, New Jersey, United States

Site #279

Greensboro, North Carolina, United States

Site #250

Portland, Oregon, United States

Site #265

Sugarloaf, Pennsylvania, United States

Site #311

Warwick, Rhode Island, United States

Site #295

Fountain Inn, South Carolina, United States

Site #255

Summerville, South Carolina, United States

Site #291

Kingsport, Tennessee, United States

Site #326

Knoxville, Tennessee, United States

Site #316

Murfreesboro, Tennessee, United States

Site #337

Houston, Texas, United States

Site #299

Longview, Texas, United States

Site #224

San Antonio, Texas, United States

Site #281

Layton, Utah, United States

Site #345

West Jordan, Utah, United States

Site #267

Richmond, Virginia, United States

Site #339

Spokane, Washington, United States

Site #343

Morgantown, West Virginia, United States

Countries

United States

References

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. 2023 Jan;24(1):119-133. doi: 10.1007/s40257-022-00733-9. Epub 2022 Oct 26.

Reference Type: DERIVED

PMID: 36287306 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35830173 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NI-MC304

Identifier Type: -

Identifier Source: org_study_id