Tinea Pedis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis
Verified date | December 2013 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 290 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing University Hospital N°3 | Beijing | |
China | Peking University First Hospital | Beijing | |
China | The Second Affiliated Hospital of Sun Yat-sen University Guangzhou | Guangdong | |
China | The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | |
China | Chinese Academy of Medical Sciences | Jiangsu | |
China | Huashan Hospital, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Novartis |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 = mild = moderate = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18 |
week 6 | No |
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 = mild = moderate = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18 |
week 6 | No |
Secondary | Number of Subjects With Adverse Event | Number of Subjects with adverse event | 6 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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