Health Condition 1: null- Tinea (dermatophytosis) excluding hair and nails
Conditions
Interventions
Intervention1: Sertaconazole: Topical sertaconazole nitrate 2% ( w/w in cream base) applied twice daily for 4 weeks.
Intervention2: Eberconazole: Topical eberconazole nitrate 1% (w/w in cream base) ap
Sponsors
Department of Pharmacology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients suffering from dermatophyte infection in the form of localized tinea lesions such as tinea corporis and tinea cruris. 2. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or breast feeding. 2. Patients with disseminated tinea infection. Patients with uncontrolled diabetes mellitus or severely immunocompromising disorders like HIV/AIDS. 3. Patients with serious disease of vital organs like heart, lungs, liver, kidney or bone marrow. 4. Patients suffering from alcoholism, other substance abuse disorders or active psychiatric disorders. 5. Patients with history of hypersensitivity to systemic or topical formulations of azole antifungals including miconazole, sertaconazole or eberconazole. 6. Participation in another clinical trial within last 30 days. 7. Any other condition, which in the opinion of the principal investigator, will prevent the subject from complying with visit schedules and instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure at 4 weeks â?? implying resolution of the lesion and associated symptoms.Timepoint: Baseline 2 weeks 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Total Symptom Score (TSS) based on erythema, scaling, and pruritus scores.Timepoint: Baseline 2 weeks 4 weeks;Clinical cure at 2 weeks.Timepoint: 2 weeks;Overall response at 4 weeks based on 6 point global response scale.Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Avijit Hazra
IPGMER Kolkata
Outcome results
None listed