Health Condition 1: B354- Tinea corporis
Conditions
Interventions
Sponsors
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 |
|---|---|
| 100% Clinical cure (Disappearance of original lesions with or without residual pigmentation)Timepoint: 4th week and 6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance measured by receiving empty strips and tubes of drugs givenTimepoint: 2nd, 4th, 6th week;Global cure (combined mycological and clinical cure)Timepoint: 6th week;Mycological cure defined as negative KOH microscopy and negative cultureTimepoint: 4th week and 6th week;Quality of life assessed by using vernacular version of Dermatology Life Quality Index (DLQI).Timepoint: baseline, 6th week;Safety parameter: Routine laboratory investigations: Routine hemogram, random blood sugar, urea, creatinine, liver function tests (LFT).Timepoint: Baseline, 4th week;Grade of clinical improvement: 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: 2nd, 4th, 6th week;Safety parameter: Spontaneously reported adverse events and those elicited by the clinicianTimepoint: 2nd, 4th, 6th week | — |
Countries
India
Contacts
Bankura Sammilani Medical College