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Trial record 1 of 1 for:    HTS-519
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Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Hallux, Inc.
Information provided by (Responsible Party):
Hallux, Inc. Identifier:
First received: June 5, 2016
Last updated: July 21, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Drug: HTS-519 Insert
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hallux, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: July 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HTS-519 Insert
Active treatment
Drug: HTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
Other Name: HTS-519 Biodegradable Micro Insert


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and females 18 - 74 years of age inclusive
  • Fungal toenail infection of one or both of the large (great) toenails
  • The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
  • Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit

Exclusion Criteria:

  • History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
  • Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
  • Significant confounding conditions as assessed by the study doctor
  • Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • No administration of systemic antifungal medications within 6 months prior to screening visit
  • No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
  • Tinea pedis (athlete's foot) that would require systemic treatment

Other protocol-defined inclusion/exclusion criteria may apply

  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 identifier: NCT02798380

Contact: Henk-Andre Kroon, MD 8003809150

United States, Arizona
Physicians Research Group Recruiting
Mesa, Arizona, United States, 85206
Contact: Robert Wallace    480-889-1211   
Sponsors and Collaborators
Hallux, Inc.
Study Director: Henk-Andre Kroon, MD Hallux, Inc.
  More Information

Additional Information:
Responsible Party: Hallux, Inc. Identifier: NCT02798380     History of Changes
Other Study ID Numbers: HTS-002B
Study First Received: June 5, 2016
Last Updated: July 21, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases processed this record on May 25, 2017