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

Novan, Inc.1 site in 1 country222 target enrollmentJuly 19, 2016

ConditionsTinea Pedis

InterventionsSB208 2%SB208 4%SB208 16%Vehicle Gel

DrugsSB208 2%SB208 4%SB208 16%Vehicle Gel

Overview

Phase: Phase 2
Intervention: SB208 2%
Conditions: Tinea Pedis
Sponsor: Novan, Inc.
Enrollment: 222
Locations: 1
Primary Endpoint: Fungal culture result
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 19, 2016

End Date

February 1, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novan, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
•T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site