Back to resultsSB208 for the Treatment of Tinea Pedis
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 2
Locations
Dominican Republic
Study Type
Interventional
Intervention
SB208 2%
SB208 4%
SB208 16%
Vehicle Gel
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis
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
Sites / Locations
- Instituto Dermatológico y Cirugía de Piel,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SB208 2%
SB208 4%
SB208 16%
Vehicle Gel
Arm Description
Apply once daily to one or both feet for 14 days
Apply once daily to one or both feet for 14 days
Apply once daily to one or both feet for 14 days
Apply once daily to one or both feet for 14 days
Outcomes
Primary Outcome Measures
Fungal culture result
Negative fungal culture from target lesion
Secondary Outcome Measures
Clinical cure
Amelioration of signs and symptoms of tinea pedis
Mycological cure
No evidence of fungal infection based on skin scraping and culture
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02860052
Brief Title
SB208 for the Treatment of Tinea Pedis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB208 2%
Arm Type
Experimental
Arm Description
Apply once daily to one or both feet for 14 days
Arm Title
SB208 4%
Arm Type
Experimental
Arm Description
Apply once daily to one or both feet for 14 days
Arm Title
SB208 16%
Arm Type
Experimental
Arm Description
Apply once daily to one or both feet for 14 days
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Apply once daily to one or both feet for 14 days
Intervention Type
Drug
Intervention Name(s)
SB208 2%
Other Intervention Name(s)
NVN1000 4%
Intervention Description
Apply once daily to one or both feet for 14 days
Intervention Type
Drug
Intervention Name(s)
SB208 4%
Other Intervention Name(s)
NVN1000 8%
Intervention Description
Apply once daily to one or both feet for 14 days
Intervention Type
Drug
Intervention Name(s)
SB208 16%
Other Intervention Name(s)
NVN1000 32%
Intervention Description
Apply once daily to one or both feet for 14 days
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Other Intervention Name(s)
Vehicle
Intervention Description
Apply once daily to one or both feet for 14 days
Primary Outcome Measure Information:
Title
Fungal culture result
Description
Negative fungal culture from target lesion
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Clinical cure
Description
Amelioration of signs and symptoms of tinea pedis
Time Frame
6 wks
Title
Mycological cure
Description
No evidence of fungal infection based on skin scraping and culture
Time Frame
6 wks
Other Pre-specified Outcome Measures:
Title
Incidence of treatment-emergent adverse events
Description
Summary of treatment emergent adverse events by treatment group
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Joyce Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Dermatológico y Cirugía de Piel,
City
Santo Domingo
Country
Dominican Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SB208 for the Treatment of Tinea Pedis
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