Tinea Pedis MedDRA version: 21.1 Level: PT Classification code 10043873 Term: Tinea pedis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Clotrimazol ATB 10mg/g cream
Pharmaceutical Form: Cream
Trade Name: Canesten 10mg/g cream
Pharmaceutical Form: Cream
Sponsors
ANTIBIOTICE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults between 18 and 80 years, both genders 2. Skin fungal culture obtained at baseline at the target site. Only subjects with a pre-treatment baseline skin fungal culture from the target site that is positive for T. rubrum, T. mentagrophytes or E. flocossum are to be included in the primary endpoint analysis. Subjects with a negative baseline fungal culture will be excluded from the primary endpoint analysis but included in the safety population for the safety analysis. 3. The presence of tinea pedis infection, with lesions localized to the interdigital spaces and/or plantar lesions and/or sides and/or dorsum of the involved foot and confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination 4. A target lesion will be identified as the most severe lesion and evaluated throughout the study. At inclusion, the sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus (on a scale of 0 to 3, where 2 indicates moderate severity). 5. Female of child bearing potential are to use a reliable method of contraception during the study (condom, intra-uterin device, oral, transdermal, injected or implanted hormonal contraceptives) 6. The subject is willing and able to consent for the participation in the clinical trial 7. Subject must be able to understand the requirements of the study and willing to comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 184
Exclusion criteria
Exclusion criteria: 1. Known treatment with oral or injectable steroids during the study period 2. Any oral antifungals within 4 weeks of the study inclusions 3. Use of topical corticosteroids or any other topical antipruritic agents on the feet within 72 hours of the study start 4. Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry 5. Use of any antihistamines within 72 hours of the study start and during the study 6. Any known hypersensitivity to antifungal agents 7. Evidence of any concurrent dermatophytes infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis 8. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy 9. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance 10. Subjects who in Investigator's opinion would be non-compliant 11. Female subjects that are pregnant or lactating or planning to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Therapeutic cure (clinical and mycological cure) at day 28. Clinical Cure is based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom will be evaluated using a 0-3 points rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was = 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient is considered a Clinical Cure ;Secondary Objective: 1.Therapeutic Cure – subjects with clinical and mycological cure at day 7 2.Mycologic Cure at day 28- Negative KOH and fungal culture at day 28 3.Clinical cure at day 28 – the following signs and symptoms are rated at each visit: Erythema; Fissuring Maceration; Vesiculation; Desquamation/scaling; Exudation Pruritus; Stinging/Burning. Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom 1= Mild - obvious but minimal involvement 2= Moderate - something that is easily noted 3= Severe - quite marked Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2 4.Safety Profile comparison between the 2 treatment arms 5.Impact of tinea pedis infection on Quality of Life (QoL) ;Primary end point(s): Therapeutic cure at day 28;Timepoint(s) of evaluation of this end point: Visit 4 - day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Therapeutic cure at day 7; Mycological cure at day 28; Clinical cure at day 28; Safety profile comparison Impact on QoL;Timepoint(s) of evaluation of this end point: Day 7 and day 28 | — |
Countries
Hungary, Romania
Contacts
Public ContactMihaela Mosnegutu
ANTIBIOTICE SA
Outcome results
None listed