SB208 for the Treatment of Tinea Pedis

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860052
• Other study ID #: NI-AF201
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: November 2018
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 1, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• SB208 2%
Apply once daily to one or both feet for 14 days
• SB208 4%
Apply once daily to one or both feet for 14 days
• SB208 16%
Apply once daily to one or both feet for 14 days
• Vehicle Gel
Apply once daily to one or both feet for 14 days

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatológico y Cirugía de Piel,	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-emergent adverse events	Summary of treatment emergent adverse events by treatment group	6 weeks
Primary	Fungal culture result	Negative fungal culture from target lesion	2 weeks
Secondary	Clinical cure	Amelioration of signs and symptoms of tinea pedis	6 wks
Secondary	Mycological cure	No evidence of fungal infection based on skin scraping and culture	6 wks