Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: EBERCONAZOLE 1% CREAM: Once a day topical application over the lesion for two weeks
Control Intervention1: TERBINAFINE 1 % CREAM: Once a day topical application over the lesion for two
Sponsors
Dr Nidarsan Viswanathan
Eligibility
Inclusion criteria
Inclusion criteria: 1)age of patient more than 18 years 2)patient is willing and able to provide written informed consent 3)patient having a clinical diagnosis of Tinea versicolor with lesions occupying less than 10% body surface area on face,neck,upper chest and upper back. 4)patients having tinea versicolor confirmed by microscopic KOH test.
Exclusion criteria
Exclusion criteria: 1)patient age less than 18 years 2)Pregnant and lactating females patients 3)patients with all other types of tinea infections 4)patients having history of intolerance or hypersensitivity to study drugs 5)patients who had recieved systemic or topical antifungal treatment within one month. 6)patients with serious concomitant illness which could prevent completion of study 7)Patients who has extensive involvement with tinea versicolor and patients with contact dermatitis,atopic dermatitis,psoriasis or other skin diseases. 8)patient is unwilling or unable to sign the informed consent 9)patients who are taking immunosuppressive drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)to compare the clinical improvement in symptoms pruritis,scaling and erythema on a scale of 0-3 by Physicians 4 point scale,assessed based on change from baseline,1st week,2nd week and at end of 4th week. 2)to compare mycological cure between baseline and at end of 4th week based on KOH mount. 3)global clinical response assessment which is based on clinical cure plus mycological cure. 4)assessment of improvement based on patients visual analogue scale. Timepoint: 1)to compare from baseline(0 weeks),end of 1st week,2nd week and at end of 4th week according to physicians 4 point assessment scale. 2)to compare mycological cure between baseline (0 weeks) and at end of 4th week 3)during visits at end of 1st week,2nd week and 4th week. 4)during visits at end of 1st week,2nd week and 4th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of once a day application of topical eberconazole 1% cream versus terbinafine 1% cream in patients of tinea versicolor in terms of occurence of adverse effects.Timepoint: 0 to 4 weeks | — |
Countries
India
Contacts
Public ContactDr Nidarsan Viswanathan
Sri Ramachandra Institute of Higher education and Research,Porur,Chennai-600116
Outcome results
None listed