Tinea Pedis
Conditions
Keywords
Tinea pedis, Terbinafine film forming solution
Brief summary
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.
Interventions
DRUGTerbinafine
1% single application
DRUGTerbinafine Placebo
single application
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign & symptom score and positive microscopy
Exclusion criteria
* Allergy to the allylamine class of antimycotics or excipients in the formulation. * Chronic, hyperkeratotic plantar (moccasin) tinea pedis * Other fungal disease or intertrigo * Other abnormal findings on the affected foot * Systemic antifungal or antimicrobial treatment within the last 3 months * Topical treatment for skin lesions on feet within the last 3 months * Diabetes mellitus and peripheral artery occlusive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | week 6 | 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 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Clinical Signs and Symptoms (S/S) Scores | week 6 | 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 1. = mild 2. = moderate 3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18 |
| Number of Subjects With Adverse Event | 6 weeks | Number of Subjects with adverse event |
Countries
China
Participant flow
Recruitment details
Study start 27 Aug 2011 end 14 Feb 2012
Pre-assignment details
Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo
Participants by arm
| Arm | Count |
|---|---|
| Terbinafine Drug | 145 |
| Placebo Drug | 145 |
| Total | 290 |
Baseline characteristics
| Characteristic | Terbinafine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.27 years STANDARD_DEVIATION 12.805 | 34.05 years STANDARD_DEVIATION 11.936 | 34.66 years STANDARD_DEVIATION 12.372 |
| Sex: Female, Male Female | 50 Participants | 46 Participants | 96 Participants |
| Sex: Female, Male Male | 95 Participants | 99 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 146 | 7 / 144 |
| serious Total, serious adverse events | 0 / 146 | 0 / 144 |
Outcome results
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 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18
Time frame: week 6
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terbinafine | Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | 73 participants |
| Placebo | Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | 10 participants |
Secondary
Number of Subjects With Adverse Event
Number of Subjects with adverse event
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terbinafine | Number of Subjects With Adverse Event | 9 participants |
| Placebo | Number of Subjects With Adverse Event | 11 participants |
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 1. = mild 2. = moderate 3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18
Time frame: week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Terbinafine | Total Clinical Signs and Symptoms (S/S) Scores | 1.6 units on a scale |
| Placebo | Total Clinical Signs and Symptoms (S/S) Scores | 4.7 units on a scale |