Foot Dermatoses
Conditions
Keywords
Onychomycosis, antifungal
Brief summary
The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis. The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
Detailed description
Study center: A total of 50 subjects were to be included in 1 site in Iceland. Methodology: * Group Loceryl Nail Lacquer+ Cosmetic Varnish: * Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails, * Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails. * Group Loceryl Nail Lacquer alone: \- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails. * All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).
Interventions
DRUGLoceryl NL + Cosmetic varnish
Loceryl NL + Cosmetic varnish once/week for 12 weeks
DRUGLoceryl NL 12 weeks
Loceryl NL once/week for 12 weeks
DRUGLoceryl NL 15 months
Loceryl once/week for additional 15 months
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized. 15 months of treatment with Loceryl NL alone had an open study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail * Subjects must have maximum of 50% of nail distal edge involved * Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening
Exclusion criteria
* Subjects with clinically important abnormal physical findings at the Screening/Baseline visit * Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit * Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Antifungal Activity of Loceryl Nail Lacquer | Week 12 | Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails |
Secondary
| Measure | Time frame |
|---|---|
| Absence of Dermatophytes in Nail Samples Culture | Week 12 |
Countries
Iceland
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Loceryl NL+Cosmetic Varnish Loceryl NL+Cosmetic varnish once/week for 12 weeks | 26 |
| Loceryl NL 12 Weeks Loceryl NL once/week for 12 weeks | 24 |
| Loceryl NL15 Months Loceryl NL once/week for 15 months | 0 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Loceryl NL 12 Weeks | Loceryl NL+Cosmetic Varnish | Total |
|---|---|---|---|
| Age, Categorical Treatment period <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Treatment period >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Treatment period Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Continuous Treatment Period | 53.7 years STANDARD_DEVIATION 12.5 | 55.1 years STANDARD_DEVIATION 12 | 54.4 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Iceland | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Treatment Period Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Treatment Period Male | 20 Participants | 19 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 29 |
| other Total, other adverse events | 3 / 26 | 4 / 24 | 10 / 29 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 2 / 29 |
Outcome results
Primary
Measurement of Antifungal Activity of Loceryl Nail Lacquer
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loceryl NL+Cosmetic Varnish | Measurement of Antifungal Activity of Loceryl Nail Lacquer | 53.6 Milimeter | Standard Deviation 9.1 |
| Loceryl NL 12 Weeks | Measurement of Antifungal Activity of Loceryl Nail Lacquer | 53.5 Milimeter | Standard Deviation 6.2 |
Secondary
Absence of Dermatophytes in Nail Samples Culture
Time frame: Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loceryl NL+Cosmetic Varnish | Absence of Dermatophytes in Nail Samples Culture | 25 participants |
| Loceryl NL 12 Weeks | Absence of Dermatophytes in Nail Samples Culture | 23 participants |