Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: Fluconazole 150 Mg: Fluconazole 150 Mg
Once Daily For 8 Weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr DG Saple
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18-65 years. 2. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. 3. Subjects with epidermal dermatophytosis confirmed by presence of fungal hyphae in KOH (potassium hydroxide). Dermatophytosis classified clinically into one of following types: ? Tinea corporis (body) ? Tinea cruris (groin) 4. Preparation of skin scrapings from over the lesion at baseline visit Subjects meting all the inclusion criteria will be enrolled in the trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with underlying immunosuppression 2. Pregnant or lactating women 3. Secondarily infected or eczematized lesions 4. Subjects who received any type of anti-fungal therapy within 14 days prior to baseline visit 5. Subjects who applied any other topical agent over the lesions prior to baseline visit 6. Subjects incapable of understanding the protocol 7. Patients with urine creatinine clearance 8. Any other disease, as judged by investigator (Uncontrolled diabetes, uncontrolled hypertension etc.) might not be suitable for subjects to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary objective of this study is to find out safety and tolerability of the investigational product. The safety and tolerability of the investigational product will be assessed by the Clinical AEs, including laboratory abnormalitiesTimepoint: Day 1 Week 2 Week 4 Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in improvement in subjective parameters (Clinical Cure): Erythema Scaling Pruritis Evalution to be based on arbitrary grading scale; Total Sign and Symptom Score (TSSS) assessed on four point scale (0- absent; 1- mild; 2- moderate; 3- severe) Mycological cure rate of KOH examination of skin scrap (Direct Microscopy) Timepoint: (Day 1) Week 2 (Day 14) Week 4 (Day 28) Week 8 (Day 56) | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Consultant
Outcome results
None listed