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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Onychomycosis
Intervention Drug: Efinaconazole Topical
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Group, Receiving Medication
Hide Arm/Group Description

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Period Title: Overall Study
Started 40
Completed 36
Not Completed 4
Arm/Group Title Intervention Group, Receiving Medication
Hide Arm/Group Description

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
58.15  (9.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
17
  42.5%
Male
23
  57.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 40 participants
Hispanic
31
  77.5%
African-American
4
  10.0%
White
4
  10.0%
Asian
1
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Primary Endpoint - Efficacy
Hide Description 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).
Time Frame 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group, Receiving Medication
Hide Arm/Group Description:

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
4
  11.1%
2.Secondary Outcome
Title Secondary Endpoint - Efficacy
Hide Description The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.
Time Frame 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group, Receiving Medication
Hide Arm/Group Description:

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
21
  58.3%
3.Secondary Outcome
Title Secondary Endpoint - Efficacy
Hide Description The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
Time Frame 50 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
Hide Description The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Time Frame 50 weeks
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group, Receiving Medication
Hide Arm/Group Description

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Efinaconazole Topical: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

All-Cause Mortality
Intervention Group, Receiving Medication
Affected / at Risk (%)
Total   0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group, Receiving Medication
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Group, Receiving Medication
Affected / at Risk (%) # Events
Total   2/40 (5.00%)    
Skin and subcutaneous tissue disorders   
Application site vesicles, local   2/40 (5.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Shofler
Organization: Western University of Health Sciences
Phone: 9097063898
EMail: dshofler@westernu.edu
Layout table for additonal information
Responsible Party: Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT03168841     History of Changes
Other Study ID Numbers: 2014-26
First Submitted: May 11, 2017
First Posted: May 30, 2017
Results First Submitted: October 1, 2019
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019