Clinical Trial: Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail

Brief Summary: The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.

Detailed Summary:
Sponsor: Hallux, Inc.

Current Primary Outcome: Complete Cure [ Time Frame: Week 48 ]

Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete Cure [ Time Frame: Week 24 and 36 ]
    Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
  • Effective Treatment [ Time Frame: Week 24, 36 and 48 ]
    Effective treatment is defined as negative KOH microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail.
  • Clinical Cure [ Time Frame: Week 12, 16, 20, 24, 36 and 48 ]
    Clinical cure is defined as no residual involvement of the target toenail.


Original Secondary Outcome: Same as current

Information By: Hallux, Inc.

Dates:
Date Received: June 5, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: July 21, 2016
Last Verified: July 2016