SB208 for the Treatment of Tinea Pedis

Sponsor

Novan, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02860052

Collaborator

(none)

222

Enrollment

Location

Arms

6.5

Actual Duration (Months)

34.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: SB208 2% Drug: SB208 4% Drug: SB208 16% Drug: Vehicle Gel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jul 19, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Fungal culture result [2 weeks]
Negative fungal culture from target lesion

Secondary Outcome Measures

Clinical cure [6 wks]
Amelioration of signs and symptoms of tinea pedis
Mycological cure [6 wks]
No evidence of fungal infection based on skin scraping and culture

Other Outcome Measures

Incidence of treatment-emergent adverse events [6 weeks]
Summary of treatment emergent adverse events by treatment group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Dermatológico y Cirugía de Piel,	Santo Domingo		Dominican Republic

Sponsors and Collaborators

Novan, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novan, Inc.

ClinicalTrials.gov Identifier:

NCT02860052

Other Study ID Numbers:

NI-AF201

First Posted:

Aug 9, 2016

Last Update Posted:

Jan 10, 2019

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Tinea

Tinea Pedis

Study Results

No Results Posted as of Jan 10, 2019