SB208 for the Treatment of Tinea Pedis

January 8, 2019 updated by: Novan, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Instituto Dermatológico y Cirugía de Piel,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB208 2%
Apply once daily to one or both feet for 14 days
Drug: SB208 2%
Apply once daily to one or both feet for 14 days
Other Names:
  • NVN1000 4%
Experimental: SB208 4%
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
Other Names:
  • NVN1000 8%
Experimental: SB208 16%
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
Other Names:
  • NVN1000 32%
Placebo Comparator: Vehicle Gel
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
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fungal culture result
Time Frame: 2 weeks
Negative fungal culture from target lesion
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: 6 wks
Amelioration of signs and symptoms of tinea pedis
6 wks
Mycological cure
Time Frame: 6 wks
No evidence of fungal infection based on skin scraping and culture
6 wks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: 6 weeks
Summary of treatment emergent adverse events by treatment group
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novan, Inc.

Investigators

  • Study Director: M Joyce Rico, MD, Novan, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-AF201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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