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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000544-26 | EudraCT Number |
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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.
Study center:
A total of 50 subjects were to be included in 1 site in Iceland.
Methodology:
Group Loceryl Nail Lacquer+ Cosmetic Varnish:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigator blinded Loceryl NL+ Cosmetic varnish | Experimental | Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails |
|
| Investigator blinded Loceryl NL alone | Experimental | Loceryl NL once/week for 12 weeks on right or left foot toenails |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loceryl NL + Cosmetic varnish | Drug | Loceryl NL + Cosmetic varnish once/week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Antifungal Activity of Loceryl Nail Lacquer | Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Dermatophytes in Nail Samples Culture | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Principal Investigator | Reykjavik | Iceland |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Loceryl NL+ Cosmetic Varnish | Loceryl NL + Cosmetic varnish once/week for 12 weeks |
| FG001 | Loceryl NL 12 Weeks | Loceryl NL once/week for 12 weeks |
| FG002 | Loceryl NL 15 Months | Loceryl NL once/week for additional 15 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12 Weeks Treament |
|
| ||||||||||||||||||
| Additional 15 Months Treatment |
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Loceryl NL+Cosmetic Varnish | Loceryl NL+Cosmetic varnish once/week for 12 weeks |
| BG001 | Loceryl NL 12 Weeks | Loceryl NL once/week for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Antifungal Activity of Loceryl Nail Lacquer | Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails | Posted | Mean | Standard Deviation | Milimeter | Week 12 |
|
|
Adverse events are collected during both study periods (Treatment period of 12 weeks and additional period of 15 months treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loceryl NL+Cosmetic Varnish | Loceryl NL+Cosmetic varnish once/week for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARCINOMA SQUAMOCELLULARE IN LEFT TONSILLARY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzaneh Sidou Clinical Project Manager | Galderma | 04 93 95 70 51 | 33 | farzaneh.sidou@galderma.com |
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| ID | Term |
|---|---|
| D005533 | Foot Dermatoses |
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014005 | Tinea |
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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
| Loceryl NL 12 weeks | Drug | Loceryl NL once/week for 12 weeks |
|
| Loceryl NL 15 months | Drug | Loceryl once/week for additional 15 months |
|
| NOT COMPLETED |
|
|
| BG002 | Loceryl NL15 Months | Loceryl NL once/week for 15 months |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Treatment period: 50 subjects are included in two arms for 12 weeks | 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 | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Not all subjects randomized in treatment period (50) were eligible to apply Loceryl NL 15 additional months (29 subjects only were eligible) | Count of Participants | Participants |
|
| Region of Enrollment | 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 | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Absence of Dermatophytes in Nail Samples Culture | Posted | Number | participants | Week 12 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 3 |
| 26 |
| EG001 | Loceryl NL 12 Weeks | Loceryl NL alone once/week for 12 weeks | 0 | 24 | 0 | 24 | 4 | 24 |
| EG002 | Loceryl NL 15 Months | Loceryl NL once/week for additional 15 months | 0 | 29 | 2 | 29 | 10 | 29 |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
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| D003881 |
| Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |