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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001237-24 | EudraCT Number |
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The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
A total of 20 subjects are to be included in 1 site in Germany.
Methodology:
Subjects will receive the following treatments on the right or left toenails:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loceryl NL | Experimental | Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot |
|
| Ciclopirox NL | Active Comparator | Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loceryl NL | Drug | Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of "in Label" Adherent Subjects | Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Schaller | Universitäts-Hautklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tübingen | Germany |
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Subjects at screening had a mycological sampling of affected great toenail and for inclusion subjects shoud have both direct microscopy and culture results positive at Baseline
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| ID | Title | Description |
|---|---|---|
| FG000 | Loceryl NL and Ciclopirox NL | Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loceryl NL + Ciclopirox NL | Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent of "in Label" Adherent Subjects | Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks) | Intention To Treat popoulation (ITT) | Posted | Number | percentage of participants | Week 12 |
|
During the study (12 weeks)
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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 + Ciclopirox NL | Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed Note: Adverse Events are not available for each intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzaneh SIDOU Clinical Project Manager | Galderma | 0493957051 | 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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Intra-individual study
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|
| Ciclopirox NL | Drug | Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12 | ITT population | Posted | Number | percentage of participants | Week 12 |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| Bronchiolitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Headache | Nervous system disorders | 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 |