Trial Outcomes & Findings for 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 (NCT NCT03110029)
NCT ID: NCT03110029
Last Updated: 2019-06-27
Results Overview
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?
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
52 weeks
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Study Group (Frequently Wears Toenail Polish)
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.
|
Control Group (no Toenail Polish)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Study Group (Frequently Wears Toenail Polish)
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.
|
Control Group (no Toenail Polish)
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Wearing Toenail Polish
n=7 Participants
Subject will have Efinaconazole 10% application and nail polish
Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution
Application of nail polish
|
Abstain From Wearing Toenail Polish
n=6 Participants
Subject will have Efinaconazole 10% application and no nail polish
Efinaconazole 10% (Jublia): Topical Efinaconazole 10% solution
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
19-70
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts.
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?
Outcome measures
| Measure |
Wearing Toenail Polish
n=6 Participants
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
|
Abstain From Wearing Toenail Polish
n=5 Participants
Subject will have Efinaconazole 10% application and no nail polish
Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution
|
|---|---|---|
|
Percentage of Nail Polish Disruption Using the Likert Scale
|
0.6 percentage of nail polish disruption
Interval 0.0 to 100.0
|
0 percentage of nail polish disruption
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 52 weekPopulation: 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.
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.
Outcome measures
| Measure |
Wearing Toenail Polish
n=6 Participants
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
|
Abstain From Wearing Toenail Polish
n=5 Participants
Subject will have Efinaconazole 10% application and no nail polish
Efinaconazole 10% (Jublia): Topical efinaconazole 10% solution
|
|---|---|---|
|
Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
|
0.56 percentage change target nail
Interval 0.0 to 100.0
|
0.54 percentage change target nail
Interval 0.0 to 100.0
|
Adverse Events
Efinaconazole 10% and Nail Polish
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Efinaconazole 10% Without Nail Polish
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place