Phase 2 N=256 Randomized Double-blind Treatment

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

Molluscum Contagiosum

Bottom Line

View on ClinicalTrials.gov: NCT03436615 ↗

Enrolled (actual)

256

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Proportion of Subjects Achieving Complete Clearance at Week 12 — 5; 16; 13; 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SB206 4% (Drug); SB206 8% (Drug); SB206 12% (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Novan, Inc.
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Achieving Complete Clearance at Week 12	5; 16; 13; 18; 12	—
SECONDARY Proportion of Subjects Achieving Complete Clearance at Each Visit	0; 1; 0; 1; 0; 1	—
SECONDARY Time to First Complete Clearance	NA; 100.0; 91.0; 85.0; 93.0	—
SECONDARY Proportion of Subjects Achieving 75% Reduction at Each Visit	1; 1; 3; 3; 1; 4	—
SECONDARY Mean Change in Molluscum Contagiosum at Each Visit	-1.5; 0; -2.5; -4.0; 0.7; -1.9	—
SECONDARY Percent Change in Molluscum Contagiosum at Each Visit	0.0; 10.1; -4.7; -11.1; 8.7; -4.4	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03436615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.