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Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish

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ClinicalTrials.gov Identifier: NCT03110029
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : March 20, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Onychomycosis of Toenail
Interventions Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
Other: Application of Nail Polish
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Group (Frequently Wears Toenail Polish) Control Group (no Toenail Polish)
Hide Arm/Group Description

Patients who self-identified as frequently wearing toenail polish were placed in the study group.

Inclusion criteria consisted of being female and aged 19-70 with distal and lateral subungual onychomycosis (DLSO) effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.

Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks.

The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study.

Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.

Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks.

Period Title: Overall Study
Started 7 6
Completed 6 5
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Wearing Toenail Polish Abstain From Wearing Toenail Polish Total
Hide Arm/Group Description

Subject will have Efinaconazole 10% application and nail polish

Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution

Application of nail polish

Subject will have Efinaconazole 10% application and no nail polish

Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
19-70 Number Analyzed 7 participants 6 participants 13 participants
7
 100.0%
6
 100.0%
13
 100.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 7 participants 6 participants 13 participants
7
 100.0%
6
 100.0%
13
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native NA [1]  NA [1]  NA [2] 
Asian NA [1]  NA [1]  NA [2] 
Native Hawaiian or Other Pacific Islander NA [1]  NA [1]  NA [2] 
Black or African American NA [1]  NA [1]  NA [2] 
White NA [1]  NA [1]  NA [2] 
More than one race NA [1]  NA [1]  NA [2] 
Unknown or Not Reported NA [1]  NA [1]  NA [2] 
[1]
Not recorded
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7
 100.0%
6
 100.0%
13
 100.0%
1.Primary Outcome
Title Percentage of Nail Polish Disruption Using the Likert Scale
Hide Description

Patients will answer the following question:

Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish:

Is the quality of your polish diminished with use of Jublia?

Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts.
Arm/Group Title Wearing Toenail Polish Abstain From Wearing Toenail Polish
Hide Arm/Group Description:

Subject will have Efinaconazole 10% application and nail polish

Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution

Application of nail polish: Application of nail polish only

Subject will have Efinaconazole 10% application and no nail polish

Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution

Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: percentage of nail polish disruption
0.6
(0 to 100)
0
(0 to 100)
2.Secondary Outcome
Title Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
Hide Description Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52.
Time Frame 52 week
Hide Outcome Measure Data
Hide Analysis Population Description
We did not include results from the two participants who withdrew from the study due to personal scheduling conflicts. Results for only 11 subjects who completed the study are represented in the number of participants analyzed.
Arm/Group Title Wearing Toenail Polish Abstain From Wearing Toenail Polish
Hide Arm/Group Description:

Subject will have Efinaconazole 10% application and nail polish

Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution

Application of nail polish: Application of nail polish only

Subject will have Efinaconazole 10% application and no nail polish

Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution

Overall Number of Participants Analyzed 6 5
Mean (Full Range)
Unit of Measure: percentage change target nail
0.56
(0 to 100)
0.54
(0 to 100)
Time Frame 52 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Efinaconazole 10% and Nail Polish Efinaconazole 10% Without Nail Polish
Hide Arm/Group Description

Patients who self-identified as frequently wearing toenail polish were placed in the study group. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.

Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks.

The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study.

Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.

Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks.

All-Cause Mortality
Efinaconazole 10% and Nail Polish Efinaconazole 10% Without Nail Polish
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Efinaconazole 10% and Nail Polish Efinaconazole 10% Without Nail Polish
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Efinaconazole 10% and Nail Polish Efinaconazole 10% Without Nail Polish
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
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: Leslie Roop
Organization: UAB
Phone: 2059754917
EMail: lmroop@uabmc.edu
Layout table for additonal information
Responsible Party: Boni Elewski, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03110029    
Other Study ID Numbers: X141114004
First Submitted: October 16, 2015
First Posted: April 12, 2017
Results First Submitted: August 14, 2018
Results First Posted: March 20, 2019
Last Update Posted: June 27, 2019