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SB208 for the Treatment of Tinea Pedis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860052
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: SB208 2% Drug: SB208 4% Drug: SB208 16% Drug: Vehicle Gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SB208 2%
Apply once daily to one or both feet for 14 days
Drug: SB208 2%
Apply once daily to one or both feet for 14 days
Other Name: NVN1000 4%

Experimental: SB208 4%
Apply once daily to one or both feet for 14 days
Drug: SB208 4%
Apply once daily to one or both feet for 14 days
Other Name: NVN1000 8%

Experimental: SB208 16%
Apply once daily to one or both feet for 14 days
Drug: SB208 16%
Apply once daily to one or both feet for 14 days
Other Name: NVN1000 32%

Placebo Comparator: Vehicle Gel
Apply once daily to one or both feet for 14 days
Drug: Vehicle Gel
Apply once daily to one or both feet for 14 days
Other Name: Vehicle




Primary Outcome Measures :
  1. Fungal culture result [ Time Frame: 2 weeks ]
    Negative fungal culture from target lesion


Secondary Outcome Measures :
  1. Clinical cure [ Time Frame: 6 wks ]
    Amelioration of signs and symptoms of tinea pedis

  2. Mycological cure [ Time Frame: 6 wks ]
    No evidence of fungal infection based on skin scraping and culture


Other Outcome Measures:
  1. Incidence of treatment-emergent adverse events [ Time Frame: 6 weeks ]
    Summary of treatment emergent adverse events by treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860052


Locations
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Dominican Republic
Instituto Dermatológico y Cirugía de Piel,
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Novan, Inc.
Investigators
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Study Director: M Joyce Rico, MD Novan, Inc.
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Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02860052    
Other Study ID Numbers: NI-AF201
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations