SB208 for the Treatment of Tinea Pedis

NCT ID: NCT02860052

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-19

Study Completion Date

2017-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinea Pedis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SB208 2%

Apply once daily to one or both feet for 14 days

Group Type EXPERIMENTAL

SB208 2%

Intervention Type DRUG

Apply once daily to one or both feet for 14 days

SB208 4%

Apply once daily to one or both feet for 14 days

Group Type EXPERIMENTAL

SB208 4%

Intervention Type DRUG

Apply once daily to one or both feet for 14 days

SB208 16%

Apply once daily to one or both feet for 14 days

Group Type EXPERIMENTAL

SB208 16%

Intervention Type DRUG

Apply once daily to one or both feet for 14 days

Vehicle Gel

Apply once daily to one or both feet for 14 days

Group Type PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type DRUG

Apply once daily to one or both feet for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB208 2%

Apply once daily to one or both feet for 14 days

Intervention Type DRUG

SB208 4%

Apply once daily to one or both feet for 14 days

Intervention Type DRUG

SB208 16%

Apply once daily to one or both feet for 14 days

Intervention Type DRUG

Vehicle Gel

Apply once daily to one or both feet for 14 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NVN1000 4% NVN1000 8% NVN1000 32% Vehicle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novan, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

M Joyce Rico, MD

Role: STUDY_DIRECTOR

Novan, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Dermatológico y Cirugía de Piel,

Santo Domingo, , Dominican Republic

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Dominican Republic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NI-AF201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.