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Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

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.
 
ClinicalTrials.gov Identifier: NCT03168841
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Western University of Health Sciences

Brief Summary:

Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects.

The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects


Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Efinaconazole Topical Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : January 9, 2019
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group, receiving medication
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Drug: Efinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.




Primary Outcome Measures :
  1. Primary Endpoint - Efficacy [ Time Frame: 50 weeks ]
    The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample).


Secondary Outcome Measures :
  1. Secondary Endpoint - Efficacy [ Time Frame: 50 weeks ]
    The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.

  2. Secondary Endpoint - Efficacy [ Time Frame: 50 weeks ]
    The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.

  3. Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency) [ Time Frame: 50 weeks ]
    The secondary safety endpoint is the occurrence of adverse events (type and frequency).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.
  • Involvement of at minimum 20% of the target great toenail.

Exclusion Criteria:

  • Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis
  • Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail
  • Inability to follow through with all requisite office visits
  • Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years.
  • Active interdigital tinea pedis refractory to topical antifungal treatments
  • Known hypersensitivity to efinaconazole
  • Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes
  • Any history of oral systemic antifungal with known activity against dermatophytes

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): NCT03168841


Locations
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United States, California
Western University of Health Sciences
Pomona, California, United States, 91711
Sponsors and Collaborators
Western University of Health Sciences
  Study Documents (Full-Text)

Documents provided by Western University of Health Sciences:

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Responsible Party: Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT03168841     History of Changes
Other Study ID Numbers: 2014-26
First Posted: May 30, 2017    Key Record Dates
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Efinaconazole
Antifungal Agents
Anti-Infective Agents