Skip to main content
OpenTrials
Completed

NCT Number: NCT02860052

SB208 for the Treatment of Tinea Pedis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Dermatológico y Cirugía de Piel,

Santo Domingo, Dominican Republic

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Women who are pregnant or nursing or planning on becoming pregnant
  • Subjects with onychomycosis or moccasin-type t. pedis
  • Subjects using topical or systemic anti-fungal agents

Treatment and study plan

SB208 2%

Drug

Apply once daily to one or both feet for 14 days

Other names: NVN1000 4%

SB208 4%

Drug

Apply once daily to one or both feet for 14 days

Other names: NVN1000 8%

SB208 16%

Drug

Apply once daily to one or both feet for 14 days

Other names: NVN1000 32%

Vehicle gel

Drug

Apply once daily to one or both feet for 14 days

Other names: Vehicle

Primary outcomes

  1. Fungal culture result

    Time frame: 2 weeks

    Negative fungal culture from target lesion

Secondary outcomes

  1. Clinical cure

    Time frame: 6 wks

    Amelioration of signs and symptoms of tinea pedis

  2. Mycological cure

    Time frame: 6 wks

    No evidence of fungal infection based on skin scraping and culture

Other outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 6 weeks

    Summary of treatment emergent adverse events by treatment group

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.