SB208 for the Treatment of Tinea Pedis | NCT02860052

Studies
SB208 for the Treatment of Tinea Pedis

NCT02860052

Sponsor

Novan, Inc.

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

222Actual

Phase

Phase 2

Conditions

Tinea Pedis

Interventions

SB208 2%
SB208 4%
SB208 16%
Vehicle Gel

Countries

Dominican Republic

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2016Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Feb 1, 2017Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 4, 2016

First Posted Date

Aug 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SB208 2%	Experimental	Apply once daily to one or both feet for 14 days	Drug: SB208 2%
SB208 4%	Experimental	Apply once daily to one or both feet for 14 days	Drug: SB208 4%
SB208 16%	Experimental	Apply once daily to one or both feet for 14 days	Drug: SB208 16%
Vehicle Gel	Placebo Comparator	Apply once daily to one or both feet for 14 days	Drug: Vehicle Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB208 2%	Drug	Apply once daily to one or both feet for 14 days	SB208 2%

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M Joyce Rico, MD	Novan, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Dermatológico y Cirugía de Piel,		Santo Domingo			Dominican Republic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014008	Tinea Pedis

Ancestor Terms

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

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Browse Branches

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