NCT02860052

SB208 for the Treatment of Tinea Pedis

A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.

Detailed description

A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	SB208 2%	Apply once daily to one or both feet for 14 days
DRUG	SB208 4%	Apply once daily to one or both feet for 14 days
DRUG	SB208 16%	Apply once daily to one or both feet for 14 days
DRUG	Vehicle Gel	Apply once daily to one or both feet for 14 days

Timeline

• Start date: 2016-07-19
• Primary completion: 2017-01-01
• Completion: 2017-02-01
• First posted: 2016-08-09
• Last updated: 2019-01-10

Locations

1 site across 1 country: Dominican Republic