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This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbinafine | Experimental | Drug |
|
| Placebo | Placebo Comparator | Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbinafine | Drug | 1% single application |
| |
| Terbinafine Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent
Possible range 0 to 18 | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Clinical Signs and Symptoms (S/S) Scores | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent
Possible range : 0 to 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China | |||
| Beijing University Hospital N°3 |
Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo
Study start 27 Aug 2011 end 14 Feb 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Terbinafine | Drug |
| FG001 | Placebo | Drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Terbinafine | Drug |
| BG001 | Placebo | Drug |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent
Possible range 0 to 18 | Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study). | Posted | Number | participants | week 6 |
|
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One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.
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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 | Terbinafine | Drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorders | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project leader | Novartis | +41223633111 |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
single application |
|
| week 6 |
| Number of Subjects With Adverse Event | Number of Subjects with adverse event | 6 weeks |
| Beijing |
| 100083 |
| China |
| The Second Affiliated Hospital of Sun Yat-sen University Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | 510630 | China |
| Chinese Academy of Medical Sciences | Jiangsu | 21004 | China |
| Huashan Hospital, Fudan University | Shanghai | 200040 | China |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Drug |
| OG001 | Placebo | Drug |
|
|
| Secondary | Total Clinical Signs and Symptoms (S/S) Scores | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent
Possible range : 0 to 18 | Posted | Mean | 95% Confidence Interval | units on a scale | week 6 |
|
|
|
| Secondary | Number of Subjects With Adverse Event | Number of Subjects with adverse event | Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started. | Posted | Number | participants | 6 weeks |
|
|
|
| 0 |
| 146 |
| 0 |
| 146 |
| EG001 | Placebo | Drug | 0 | 144 | 7 | 144 |
Preliminary agreement between Novartis Consumer Health and the investigator
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |