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SB208 for the Treatment of Tinea Pedis

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02860052
Enrollment
222
Registered
2016-08-09
Start date
2016-07-19
Completion date
2017-02-01
Last updated
2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Pedis

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.

Interventions

DRUGSB208 2%

Apply once daily to one or both feet for 14 days

DRUGSB208 4%

Apply once daily to one or both feet for 14 days

DRUGSB208 16%

Apply once daily to one or both feet for 14 days

DRUGVehicle Gel

Apply once daily to one or both feet for 14 days

Sponsors

Novan, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fungal culture result2 weeksNegative fungal culture from target lesion

Secondary

MeasureTime frameDescription
Clinical cure6 wksAmelioration of signs and symptoms of tinea pedis
Mycological cure6 wksNo evidence of fungal infection based on skin scraping and culture

Other

MeasureTime frameDescription
Incidence of treatment-emergent adverse events6 weeksSummary of treatment emergent adverse events by treatment group

Countries

Dominican Republic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026