A prospective, real world, observational study to evaluate the effectiveness and safety of Eberconazole 1% cream (Ebernet®) in Indian patients with Tinea corporis and Tinea cruris
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dr Reddys Laboratories Ltd
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- EFFECTIVENESS EVALUATION
Study Overview
Brief Summary
Tinea corporis and tinea cruris are the major superficial dermatophyte infections caused by Trichophyton species which invade the keratinized tissues such as skin, hair, and nail to cause an infection. Most tinea corporis and tinea cruris infections are treated with topical agents.
Various topical antifungal agents are currently employed for the management of tinea corporis and tinea cruris as once or twice daily application for 2–4 weeks.
Eberconazole is one such topical antifungal agent approved for the treatment of cutaneous dermatophyte (cutaneous mycosis) infections. Although Ebernet**®**has been studied extensively in clinical trials, there is lack of data on efficacy and safety outcomes of Ebernet® in real world clinical setting, especially in Indian patients. Therefore, current study has been planned to evaluate the effectiveness and safety of Ebernet® in real-world clinical setting in India.
This is a prospective, observational study to collect data on the effectiveness and safety of eberconazole 1% cream in patients with tinea corporis and tinea cruris, in real world clinical setting. This study will include up to 300 Indian patients’ data recruited within 3 months from up to 10 centres, diagnosed with localized tinea cruris and tinea corporis and prescribed eberconazole 1% cream as topical treatment, by the treating physician.
The overall observation period will be 21 days±3 days, and data collection for the study will conclude with final patient visit.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex, greater than and equal to 18 years of age
- •Patients prescribed eberconazole 1% cream for topical treatment of tinea cruris and tinea corporis by the treating physician.
- •Patients willing to give written informed consent for study participation.
Exclusion Criteria
- •Patients requiring systemic anti-fungal drugs for management of their condition.
- •Pregnant and lactating women.
- •Patients with any significant medical illness that would prevent study participation, at investigator’s discretion.
Outcomes
Primary Outcomes
EFFECTIVENESS EVALUATION
Time Frame: Baseline and 2 weeks
Proportion of patients with improvement of signs and symptoms from baseline to 2 weeks of treatment with eberconazole 1% cream
Time Frame: Baseline and 2 weeks
Secondary Outcomes
- EFFECTIVENESS EVALUATION(1. Proportion of patients with improvement of signs and symptoms from baseline to 1 week and 3 weeks of treatment with eberconazole 1% cream.)
- Efficacy EVALUATION(3. Physician’s global assessment of effectiveness and safety at 1st, 2nd and 3rd week of treatment with eberconazole 1% cream.)