SB208 for the Treatment of Tinea Pedis

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: SB208 16%; Drug: Vehicle Gel; Drug: SB208 2%; Drug: SB208 4%

• Registration Number: NCT02860052
• Lead Sponsor: Novan, Inc.

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.

Study Timeline

• Study Start: 2016-07-19
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Primary Completion: 2017-01
• Study Completion: 2017-02-01
• Status Verified: 2018-11
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB208 16%	SB208 16%	Apply once daily to one or both feet for 14 days
Vehicle Gel	Vehicle Gel	Apply once daily to one or both feet for 14 days
SB208 2%	SB208 2%	Apply once daily to one or both feet for 14 days
SB208 4%	SB208 4%	Apply once daily to one or both feet for 14 days

Primary Outcome Measures

Name	Time	Method
Fungal culture result	2 weeks	Negative fungal culture from target lesion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Dermatológico y Cirugía de Piel,; 🇩🇴 Santo Domingo, Dominican Republic