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Trial record 1 of 15 for:    novan
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SB208 for the Treatment of Tinea Pedis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT02860052
First received: August 2, 2016
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
This is 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.

Condition Intervention Phase
Tinea Pedis Drug: SB208 2% Drug: SB208 4% Drug: SB208 16% Drug: Vehicle Gel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

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


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

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


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


Enrollment: 222
Study Start Date: July 2016
Estimated Study Completion Date: June 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB208 2% Drug: SB208 2%
SB208 2% once daily
Experimental: SB208 4% Drug: SB208 4%
SB208 4% once daily
Experimental: SB208 16% Drug: SB208 16%
SB208 16% once daily
Placebo Comparator: Vehicle Gel Drug: Vehicle Gel
Vehicle Gel once daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02860052

Locations
Dominican Republic
Instituto Dermatológico y Cirugía de Piel,
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Novan, Inc.
Investigators
Study Director: M Joyce Rico, MD Novan, Inc.
  More Information

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02860052     History of Changes
Other Study ID Numbers: NI-AF201
Study First Received: August 2, 2016
Last Updated: January 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 16, 2017