NCT03436615

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	SB206 4%	Twice daily
DRUG	SB206 8%	Twice daily
DRUG	SB206 12%	Once or twice daily
DRUG	Placebo	Once or twice daily

Timeline

• Start date: 2018-01-24
• Primary completion: 2018-11-03
• Completion: 2018-11-03
• First posted: 2018-02-19
• Last updated: 2023-05-06
• Results posted: 2023-05-06

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study