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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 Toenail Fungus of the Big Toenail

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. Identifier: NCT02798380
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Hallux, Inc.

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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: HTS-519 Insert Phase 2

Detailed Description:
Open label, single-site

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Treatment Related Adverse Events [ Time Frame: Up to 48 weeks ]
    Frequency and severity of Treatment Related Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT02798380

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United States, Arizona
OrthoArizona - East Valley Foot & Ankle Specialists
Mesa, Arizona, United States, 85206
Sponsors and Collaborators
Hallux, Inc.
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Study Director: Thomas Tremblay, RN, BSN Hallux, Inc.
  Study Documents (Full-Text)

Documents provided by Hallux, Inc.:
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Responsible Party: Hallux, Inc. Identifier: NCT02798380    
Other Study ID Numbers: HTS-002B
First Posted: June 14, 2016    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Nail Diseases
Skin Diseases