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

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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

Tracking Information
First Submitted Date  ICMJE May 11, 2017
First Posted Date  ICMJE May 30, 2017
Results First Submitted Date  ICMJE October 1, 2019
Results First Posted Date  ICMJE October 23, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE June 6, 2017
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03168841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • 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.
  • 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.
  • Secondary endpoint - Safety [ Time Frame: 50 weeks ]
    The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Official Title  ICMJE Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE Drug: Efinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Study Arms  ICMJE Experimental: Intervention Group, receiving medication
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Intervention: Drug: Efinaconazole Topical
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
48
Actual Study Completion Date  ICMJE January 9, 2019
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03168841
Other Study ID Numbers  ICMJE 2014-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Western University of Health Sciences
Study Sponsor  ICMJE Western University of Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Western University of Health Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP