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

Molluscum Contagiosum Clinical Trial

Official title:

A Phase 2 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Ascending Dose Study of SB206 in Subjects With Molluscum Contagiosum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436615
• Other study ID #: NI-MC201
• Status: Completed
• Phase: Phase 2
• Start date: January 24, 2018
• Est. completion date: November 3, 2018

Study information

• Verified date: April 2023
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: November 3, 2018
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Molluscum Contagiosum

Intervention

Drug:
• SB206 4%
Twice daily
• SB206 8%
Twice daily
• SB206 12%
Once or twice daily
• Placebo
Once or twice daily

Locations

Country	Name	City	State
United States	Premier Site# 259	Charleston	South Carolina
United States	Premier Site# 264	Doral	Florida
United States	Premier Site# 237	Gresham	Oregon
United States	Premier Site# 131	Houston	Texas
United States	Premier Site# 167	Houston	Texas
United States	Premier Site# 251	Indianapolis	Indiana
United States	Premier Site# 182	Las Vegas	Nevada
United States	Premier Site# 253	Lenexa	Kansas
United States	Premier Site# 117	Louisville	Kentucky
United States	Premier Site# 255	Mount Pleasant	South Carolina
United States	Premier Site# 116	Newnan	Georgia
United States	Premier Site# 252	Norman	Oklahoma
United States	Premier Site# 267	Richmond	Virginia
United States	Premier Site# 256	Salt Lake City	Utah
United States	Premier Site# 224	San Antonio	Texas
United States	Premier Site# 260	Santa Ana	California
United States	Premier Site# 266	Scottsdale	Arizona
United States	Premier Site# 257	Thornton	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Novan, Inc.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving Complete Clearance 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	Proportion of Subjects Achieving Complete Clearance at Each Visit	Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.	Week 1; Week 2; Week 4; Week 8; Week 12
Secondary	Time to First Complete Clearance	Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)	Week 12
Secondary	Proportion of Subjects Achieving 75% Reduction at Each Visit	Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit	Week 1, Week 2, Week 4, Week 8, Week 12
Secondary	Mean Change in Molluscum Contagiosum at Each Visit	Mean change from baseline in number of molluscum contagiosum lesions at each visit	Week 1, Week 2, Week 4, Week 8, Week 12
Secondary	Percent Change in Molluscum Contagiosum at Each Visit	Percent change from baseline in number of molluscum contagiosum lesions at each visit	Week 1, Week 2, Week 4, Week 8, Week 12