Clinical trial NCT04535531: A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Molluscum Contagiosum
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Therapeutics, Inc.
name: Synteract, Inc.
First posted: 2020-09-02
Enrollment: 891
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete Clearance of All Treatable MC at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: A Lesion Count of 0 or 1 of All Treatable MC at Week 12
timeFrame: 12 Weeks
measure: 90% Reduction From Baseline in the Number of All Treatable MC at Week 12
timeFrame: 12 Weeks
measure: Complete Clearance of All Treatable MC at Week 8
timeFrame: 8 Weeks
measure: Change From Baseline in the Number of All Treatable MC at Week 4
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site #312
state: Arizona
city: Hot Springs
country: United States
facility: Site #101
state: Arkansas
city: Rogers
country: United States
facility: Site #272
state: Arkansas
city: Fountain Valley
country: United States
facility: Site #336
state: California
city: Fremont
country: United States
facility: Site #329
state: California
city: Fresno
country: United States
facility: Site# 348
state: California
city: San Diego
country: United States
facility: Site #161
state: California
city: Thousand Oaks
country: United States
facility: Site #327
state: California
city: Greenwood Village
country: United States
facility: Site #325
state: Colorado
city: Apopka
country: United States
facility: Site #335
state: Florida
city: Boca Raton
country: United States
facility: Site #342
state: Florida
city: Fort Lauderdale
country: United States
facility: Site #333
state: Florida
city: Homestead
country: United States
facility: Site #334
state: Florida
city: Miami Lakes
country: United States
facility: Site #314
state: Florida
city: Miami
country: United States
facility: Site #278
state: Florida
city: Orlando
country: United States
facility: Site #341
state: Florida
city: Sanford
country: United States
facility: Site #227
state: Florida
city: Tampa
country: United States
facility: Site #305
state: Florida
city: Newnan
country: United States
facility: Site #116
state: Georgia
city: Chicago
country: United States
facility: Site #340
state: Illinois
city: Rolling Meadows
country: United States
facility: Site #253
state: Illinois
city: Evansville
country: United States
facility: Site #288
state: Indiana
city: Plainfield
country: United States
facility: Site #310
state: Indiana
city: Bowling Green
country: United States
facility: Site #328
state: Kentucky
city: Lexington
country: United States
facility: Site #347
state: Kentucky
city: Louisville
country: United States
facility: Site # 117
state: Kentucky
city: Owensboro
country: United States
facility: Site #294
state: Kentucky
city: Baton Rouge
country: United States
facility: Site #321
state: Louisiana
city: Covington
country: United States
facility: Site# 349
state: Louisiana
city: New Orleans
country: United States
facility: Site #332
state: Louisiana
city: New Orleans
country: United States
facility: Site #297
state: Louisiana
city: Rockville
country: United States
facility: Site #330
state: Maryland
city: Brighton
country: United States
facility: Site #346
state: Massachusetts
city: Clarkston
country: United States
facility: Site #274
state: Michigan
city: New Brighton
country: United States
facility: Site #121
state: Minnesota
city: Omaha
country: United States
facility: Site #338
state: Nebraska
city: Berlin
country: United States
facility: Site #201
state: New Jersey
city: Verona
country: United States
facility: Site #331
state: New Jersey
city: Greensboro
country: United States
facility: Site #279
state: North Carolina
city: Portland
country: United States
facility: Site #250
state: Oregon
city: Sugarloaf
country: United States
facility: Site #265
state: Pennsylvania
city: Warwick
country: United States
facility: Site #311
state: Rhode Island
city: Fountain Inn
country: United States
facility: Site #295
state: South Carolina
city: Summerville
country: United States
facility: Site #255
state: South Carolina
city: Kingsport
country: United States
facility: Site #291
state: Tennessee
city: Knoxville
country: United States
facility: Site #326
state: Tennessee
city: Murfreesboro
country: United States
facility: Site #316
state: Tennessee
city: Houston
country: United States
facility: Site #337
state: Texas
city: Longview
country: United States
facility: Site #299
state: Texas
city: San Antonio
country: United States
facility: Site #224
state: Texas
city: Layton
country: United States
facility: Site #281
state: Utah
city: West Jordan
country: United States
facility: Site #345
state: Utah
city: Richmond
country: United States
facility: Site #267
state: Virginia
city: Spokane
country: United States
facility: Site #339
state: Washington
city: Morgantown
country: United States
facility: Site #343
state: West Virginia
Study officials:
affiliation: Novan, Inc.
name: Tomoko Maeda Chubachi, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.