SB208 for the Treatment of Tinea Pedis

Novan

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: Vehicle Gel; Drug: SB208 4%; Drug: SB208 2%; Drug: SB208 16%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02860052

NI-AF201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 4 patient groups, including a placebo group

SB208 2%

Experimental group

Description:

Apply once daily to one or both feet for 14 days

Treatment:

Drug: SB208 2%

SB208 4%

Experimental group

Description:

Apply once daily to one or both feet for 14 days

Treatment:

Drug: SB208 4%

SB208 16%

Experimental group

Description:

Apply once daily to one or both feet for 14 days

Treatment:

Drug: SB208 16%

Vehicle Gel

Placebo Comparator group

Description:

Apply once daily to one or both feet for 14 days

Treatment:

Drug: Vehicle Gel