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Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

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ClinicalTrials.gov Identifier: NCT02798380
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : May 17, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Estimated Primary Completion Date : October 2018
Estimated 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. 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 :
  1. 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.

  2. 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.

  3. Clinical Cure [ Time Frame: Week 12, 16, 20, 24, 36 and 48 ]
    Clinical cure is defined as no residual involvement of the target toenail.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02798380


Locations
United States, Arizona
Physicians Research Group
Mesa, Arizona, United States, 85206
Sponsors and Collaborators
Hallux, Inc.
Investigators
Study Chair: Mark Taylor Hallux, Inc.

Additional Information:
Responsible Party: Hallux, Inc.
ClinicalTrials.gov Identifier: NCT02798380     History of Changes
Other Study ID Numbers: HTS-002B
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases