A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum

NCT ID: NCT03436615

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2018-11-03

Brief Summary

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

Detailed Description

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in up to approximately 192 or 256 non-immunocompromised subjects with molluscum contagiosum. Subjects who satisfy entry criteria will be randomized 3:1 to ascending, sequential dose cohorts of SB206. The highest tolerated dose will also be run in a cohort once daily. Approximately 64 subjects will be randomized to each cohort. Subjects will be treated once daily, twice daily or three times a week for up to 12 weeks. After 30 subjects randomized in a cohort have completed 2 weeks of treatment, the Data Safety Monitoring Board (DSMB) will review the available unblinded safety and tolerability data. The DSMB will determine if the data supports escalating to the next highest dose for the next cohort or if the data shows the dose is not tolerable decreasing to the next lower dose or frequency for the next cohort.

Conditions

Molluscum Contagiosum

Study Design

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

Study Groups

SB206 4%

SB206 4% topically twice daily

Group Type: EXPERIMENTAL

SB206 4%

Intervention Type: DRUG

Twice daily

SB206 8%

SB206 8% topically twice daily

Group Type: EXPERIMENTAL

SB206 8%

Intervention Type: DRUG

Twice daily

SB206 12%

SB206 12% topically once or twice daily

Group Type: EXPERIMENTAL

SB206 12%

Intervention Type: DRUG

Once or twice daily

Placebo (vehicle gel)

Vehicle Gel topically once or twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once or twice daily

Interventions

SB206 4%

Twice daily

Intervention Type: DRUG

SB206 8%

Twice daily

Intervention Type: DRUG

SB206 12%

Once or twice daily

Intervention Type: DRUG

Placebo

Once or twice daily

Intervention Type: DRUG

Other Intervention Names

NVN1000; NVN1000; NVN1000; Vehicle Gel

Eligibility Criteria

Inclusion Criteria

• Be 2 years of age or older, and in good general health;
• Have signed written informed consent form by a parent or legal guardian (assent form where required);
• Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis;
• Females 10 years of age and older must have a negative urine pregnancy test prior to randomization;
• Females 10 years of age and older must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit;
• Be willing and able to follow study instructions and likely to complete all study requirements.

Exclusion Criteria

• Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;
• Have agminated MC that could make it difficult to provide accurate lesion counts;
• Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions;
• Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to 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 OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;
• Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline;
• Have MC only in periocular area;
• Have MC only on the labia or penis;
• Female subjects who are pregnant, planning a pregnancy or breastfeeding;
• Have confirmed methemoglobin level of >3.0% at Baseline using a pulse co-oximeter;
• Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;
• Have participated in a previous study with NVN1000;
• Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Premier Research Group plc

UNKNOWN

Sponsor Role: collaborator

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomoko Maeda-Chubachi, MD

Role: STUDY_CHAIR

Novan, Inc.

Locations

Premier Site# 266

Scottsdale, Arizona, United States

Premier Site# 260

Santa Ana, California, United States

Premier Site# 257

Thornton, Colorado, United States

Premier Site# 264

Doral, Florida, United States

Premier Site# 116

Newnan, Georgia, United States

Premier Site# 251

Indianapolis, Indiana, United States

Premier Site# 253

Lenexa, Kansas, United States

Premier Site# 117

Louisville, Kentucky, United States

Premier Site# 182

Las Vegas, Nevada, United States

Premier Site# 252

Norman, Oklahoma, United States

Premier Site# 237

Gresham, Oregon, United States

Premier Site# 259

Charleston, South Carolina, United States

Premier Site# 255

Mt. Pleasant, South Carolina, United States

Premier Site# 131

Houston, Texas, United States

Premier Site# 167

Houston, Texas, United States

Premier Site# 224

San Antonio, Texas, United States

Premier Site# 256

Salt Lake City, Utah, United States

Premier Site# 267

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NI-MC201

Identifier Type: -

Identifier Source: org_study_id