Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
NCT ID: NCT02798380
Last Updated: 2021-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2016-07-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HTS-519 Insert
Active treatment
HTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
Interventions
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HTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Hallux, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Tremblay, RN, BSN
Role: STUDY_DIRECTOR
Hallux, Inc.
Locations
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OrthoArizona - East Valley Foot & Ankle Specialists
Mesa, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HTS-002B
Identifier Type: -
Identifier Source: org_study_id