Trial Outcomes & Findings for Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish (NCT NCT02321098)
NCT ID: NCT02321098
Last Updated: 2023-01-19
Results Overview
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Week 12
Results posted on
2023-01-19
Participant Flow
50 subjects included to treat their affected toenails with Loceryl NL with or without Cosmetic Varnish for 12 weeks, First Subject In (FSI) = 11 Feb 2014, Last Subject Out (LSO) = 31 Oct 2014 29 subjects without aggravation of their disease treated their toenails with Loceryl NL 15 additional months: FSI = 03 Nov 2014, LSO = 21Jan 2016
At screening all subjects had a mycological sampling of one of the diseased great toenails. Only screened subjects with both positive mycological results (direct microscopy and culture) at Baseline are randomized into one of the two arms for 12 weeks.
Participant milestones
| Measure |
Loceryl NL+ Cosmetic Varnish
Loceryl NL + Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
Loceryl NL once/week for 12 weeks
|
Loceryl NL 15 Months
Loceryl NL once/week for additional 15 months
|
|---|---|---|---|
|
12 Weeks Treament
STARTED
|
26
|
24
|
0
|
|
12 Weeks Treament
COMPLETED
|
25
|
23
|
0
|
|
12 Weeks Treament
NOT COMPLETED
|
1
|
1
|
0
|
|
Additional 15 Months Treatment
STARTED
|
0
|
0
|
29
|
|
Additional 15 Months Treatment
COMPLETED
|
0
|
0
|
21
|
|
Additional 15 Months Treatment
NOT COMPLETED
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Loceryl NL+ Cosmetic Varnish
Loceryl NL + Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
Loceryl NL once/week for 12 weeks
|
Loceryl NL 15 Months
Loceryl NL once/week for additional 15 months
|
|---|---|---|---|
|
12 Weeks Treament
Lost to Follow-up
|
1
|
1
|
0
|
|
Additional 15 Months Treatment
Lack of Efficacy
|
0
|
0
|
6
|
|
Additional 15 Months Treatment
Lost to Follow-up
|
0
|
0
|
1
|
|
Additional 15 Months Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
Baseline characteristics by cohort
| Measure |
Loceryl NL+Cosmetic Varnish
n=26 Participants
Loceryl NL+Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
n=24 Participants
Loceryl NL once/week for 12 weeks
|
Loceryl NL15 Months
Loceryl NL once/week for 15 months
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
Iceland
|
26 Participants
n=5 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
24 Participants
n=7 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
—
|
50 Participants
n=4 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
|
Age, Categorical
Treatment period · <=18 years
|
0 Participants
n=5 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
0 Participants
n=7 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
—
|
0 Participants
n=4 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
|
Age, Categorical
Treatment period · Between 18 and 65 years
|
18 Participants
n=5 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
18 Participants
n=7 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
—
|
36 Participants
n=4 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
|
Age, Categorical
Treatment period · >=65 years
|
8 Participants
n=5 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
6 Participants
n=7 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
—
|
14 Participants
n=4 Participants • In Loceryl + cosmetic varnish arm 14 subjects out of 25 and 15 subjects out of 23 in Loceryl alone arm having completed 12 weeks Treatment period, continued to apply Loceryl for additional 15 months
|
|
Age, Continuous
Treatment Period
|
55.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants • From the 50 included subjects, 48 completed the study treatment period of 12 weeks and only 29 were eligible to continue to apply 15 additional months Loceryl NL
|
53.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants • From the 50 included subjects, 48 completed the study treatment period of 12 weeks and only 29 were eligible to continue to apply 15 additional months Loceryl NL
|
—
|
54.4 years
STANDARD_DEVIATION 12.1 • n=4 Participants • From the 50 included subjects, 48 completed the study treatment period of 12 weeks and only 29 were eligible to continue to apply 15 additional months Loceryl NL
|
|
Sex: Female, Male
Treatment Period · Female
|
7 Participants
n=5 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
4 Participants
n=7 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
—
|
11 Participants
n=4 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
|
Sex: Female, Male
Treatment Period · Male
|
19 Participants
n=5 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
20 Participants
n=7 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
—
|
39 Participants
n=4 Participants • Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible)
|
PRIMARY outcome
Timeframe: Week 12Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Outcome measures
| Measure |
Loceryl NL+Cosmetic Varnish
n=25 Participants
Loceryl NL+Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
n=23 Participants
Loceryl NL once/week for 12 weeks
|
|---|---|---|
|
Measurement of Antifungal Activity of Loceryl Nail Lacquer
|
53.6 Milimeter
Standard Deviation 9.1
|
53.5 Milimeter
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Loceryl NL+Cosmetic Varnish
n=25 Participants
Loceryl NL+Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
n=23 Participants
Loceryl NL once/week for 12 weeks
|
|---|---|---|
|
Absence of Dermatophytes in Nail Samples Culture
|
25 participants
|
23 participants
|
Adverse Events
Loceryl NL+Cosmetic Varnish
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Loceryl NL 12 Weeks
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Loceryl NL 15 Months
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loceryl NL+Cosmetic Varnish
n=26 participants at risk
Loceryl NL+Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
n=24 participants at risk
Loceryl NL alone once/week for 12 weeks
|
Loceryl NL 15 Months
n=29 participants at risk
Loceryl NL once/week for additional 15 months
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOMA SQUAMOCELLULARE IN LEFT TONSILLARY
|
0.00%
0/26 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
0.00%
0/24 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
3.4%
1/29 • Number of events 1 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/26 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
0.00%
0/24 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
3.4%
1/29 • Number of events 1 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
Other adverse events
| Measure |
Loceryl NL+Cosmetic Varnish
n=26 participants at risk
Loceryl NL+Cosmetic varnish once/week for 12 weeks
|
Loceryl NL 12 Weeks
n=24 participants at risk
Loceryl NL alone once/week for 12 weeks
|
Loceryl NL 15 Months
n=29 participants at risk
Loceryl NL once/week for additional 15 months
|
|---|---|---|---|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/26 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
12.5%
3/24 • Number of events 3 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
17.2%
5/29 • Number of events 8 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/26 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
4.2%
1/24 • Number of events 1 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
10.3%
3/29 • Number of events 3 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
|
Infections and infestations
TONSILLITIS
|
7.7%
2/26 • Number of events 2 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
0.00%
0/24 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
6.9%
2/29 • Number of events 3 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
|
Infections and infestations
SINUSITIS
|
7.7%
2/26 • Number of events 2 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
0.00%
0/24 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
0.00%
0/29 • Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place