Health Condition 1: null- Tinea cruris / corporis limited variety
Conditions
Interventions
Intervention1: Amorolfine 0.25% cream: Amorolfine 0.25% cream applied locally over lesion for 4 weeks twice daily
Control Intervention1: Sertaconazole 1% cream: Sertaconazole 1% cream applied locally
Sponsors
Medical College Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: •Untreated male and non-¬pregnant female patients above 18 years of age •Acute, symptomatic tinea cruris/corporis with limited involvement i.e. limited to single body region •KOH mount showing positive results (hyphae)
Exclusion criteria
Exclusion criteria: •Pregnant or nursing females •Patients with diabetes mellitus, malignancy, renal or hepatic dysfunction •Patients who received topical antifungal agents within the past week or received systemic antifungal agents within past four weeks. •History of hypersensitivity to any of the study drugs •Patients not willing to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cureTimepoint: 2nd week,4th week and 6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of safety and efficacy At the end of treatment and test of cure, patients as well as the investigator will assess treatment for safety as well as efficacy on the Likertâ??s five point scale as- poor, fair, good, very good, excellent.Timepoint: 4th week and 6th week;Global cure (combined mycological and clinical cure). Patients will be classified as cured for this combined variable only if they are mycologically and clinically clear. All other cases will be classified as failures for this particular variableTimepoint: 4th week and 6th week;Gradation of the Clinical improvement as follows: o Grade 0 (Clinical Failure): No improvement. o Grade I: Persistence of few papular lesions or erythema with mild to moderate itching. o Grade II: Scaly lesions with or without itching. o Grade III (Clinical cure): Disappearance of original lesions with or without residual pigmentationTimepoint: 4th week and 6th week;Mycological cure (defined as negative KOH microscopy and negative culture)Timepoint: 4th week and 6th week;Quality of life judged by DLQI (Dermatology life Quality Index) questionnaireTimepoint: 2nd week, 4th week, 6th week;Routine laboratory investigations: Routine hemogram, random blood sugar, urea, creatinine, liver function tests (LFT).Timepoint: At baseline and week 4 visit;Spontaneously reported adverse events and those elicited by the clinicianTimepoint: 2nd week, 4th week, 6th week | — |
Countries
India
Contacts
Public ContactAmrita Sil
Medical College Kolkata
Outcome results
None listed