Clinical Trial: SB208 for the Treatment of Tinea Pedis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Novan, Inc.

Current Primary Outcome: Fungal culture result [ Time Frame: 2 weeks ]

Negative fungal culture from target lesion


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Novan, Inc.

Dates:
Date Received: August 2, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: January 3, 2017
Last Verified: January 2017