None listed
Conditions
Interventions
Intervention1: Naftifine cream 1 %: Once daily for 4 weeks
Control Intervention1: Terbinafine cream 1 %: Once daily for 4 weeks
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged between 18 and 65 years. 2.Patients with a clinical diagnosis of dermatophytosis. 3.Patient willing to give their informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women and women of childbearing potential who are not on an acceptable birth control methods. 2.Patients with any systemic condition predisposing them to fungal infection or with any skin disease that might interfere with the study. 3.Patients using topical antifungals, topical corticosteroids, or systemic antibacterials before 14 days of study entry. 4.Patients using systemic antifungals or corticosteroids before 4 weeks of the study entry. 5.Patients using other concomitant systemic or topical therapy with antibiotics, antimycotics or corticosteroids. 6.Patients having hypersensitivity with Naftifine or Terbinafine. 7.Patients having a serum creatinine of > 1.5 x upper limit of normal. 8.Patients having history of alcohol, narcotic or drug abuse. 9.Patients with severe renal and hepatic impairment. 10.Patients having thyroid stimulating hormone value outside the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of following symptoms using 4 point Visual Analogue Scale (VAS). 1.Percentage of patients with erythema. 2.Percentage of patients with pruritus. 3.Percentage of patients with maceration. 4.Percentage of patients with fissuring. 5.Percentage of patients with scaling. Timepoint: Baseline (Day 0), week 2 and week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Average change from baseline in Clinical Global Impression on Severity (CGI-S) in patients by investigator. 2.Clinical Global Impression on Improvement (CGI-I) in patients by investigator.Timepoint: 1.Baseline (day 0) and week 4 2.Week 2 and week 4 | — |
Countries
India
Contacts
Public ContactDr. Surendra Borgharkar
Outcome results
None listed