Health Condition 1: B354- Tinea corporis
Conditions
Interventions
Intervention1: 0.25% Amorolfine cream: Drug will be given for 4 weeks in Total and follow up done after Week 2 and end of study at Week 4
Control Intervention1: 1% Luliconazole cream
: Drug will be gi
Sponsors
Government Medical College Nagpur
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients with clinical manifestations of tinea corporis 2)Patients of 18-70 years of age. 3)Subjects of either gender. 4)Subject willing to give written informed consent. 5)Patients having a physician global assessment (PGA) composite score of at least 5 (composite score is a combined score of all clinical signs and symptoms of tinea infection)
Exclusion criteria
Exclusion criteria: 1)Patients having clinical diagnosis of tinea infections other than tinea corporis 2)Patients having extensive fungal infection 3)Patients who had received topical or oral antifungal agents up to 4 weeks before the initiation of the study 4)History of hypersensitivity to the study drugs 5)Patients who are known cases of compromised immune status 6)Patients having superadded bacterial infection 7)Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical improvement/cure at 4 weeks (the end of treatment period) w.r.t. Physician Global Assessment Scale(absence of signs and symptoms such as erythema, scaling, and pruritus)Timepoint: Proportion of patients showing improvement/clinical cure will be assessed at Week 2 and Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability assessment evaluated by systematically recording and assessing all spontaneously reported adverse events from participants during the 4 week treatment periodTimepoint: 1. Baseline (start of treatment) 2. Follow up (2 weeks after initiation) 3. End of treatment (4 weeks after initiation) Follow-up assessments at 2 weeks and 4 weeks post-treatment to evaluate Tolerability assessment done by recording and evaluating the spontaneously reported adverse events by the participants;Proportion of patients showing improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI) questionnaire.Timepoint: The DLQI questionnaire will be filled by the patient at the following time points: 1.Baseline (start of treatment) 2. End of treatment (after 4 weeks from initiation) | — |
Countries
India
Contacts
Public ContactDr Shubham Nimbhorkar
Government Medical College, Nagpur
Outcome results
None listed