Subject : Participation in surveillance “Assessment of drug utilization pattern of antifungal in Indian patients with dermatophytosis”
Dermatophytoses have always been among the commonest infective dermatoses in India. However, the current perception among practicing Indian dermatologists based on their daily experience in the outpatients' clinics is that there is a huge change in clinical profile, both qualitative and quantitative, in the patients presenting with dermatophytosis. The infection is apparently much more resilient, having a tendency to recur more frequently and the overall number of patients presenting with chronic/recurrent/recalcitrant dermatophytosis is much more. A disease that was taken for granted and hence treated with predictable results is now becoming a cause of anxiety and trepidation for the dermatologist. The recent prevalence of dermatophytosis in India ranges from 36.6–78.4%.
Ectoderm India and IADVL ITART guidelines recommend combination of systemic and topical antifungals for the management of Dermatophytosis. Topicals are recommended to be used based on ‘Rule of two’- topical antifungals means it should be applied 2 cm beyond the margin of the lesion twice a day for at least 2 weeks beyond clinical resolution.
Dermatophytosis management still remains a concern among dermatologists in India. There is a lack of recent real-world evidence on use of antifungals in patients with dermatophytosis in India.
This retrospective, cross-sectional multicenter surveillance is planned to evaluate the drug utilization pattern of antifungals in patients with dermatophytosis in India.
We invite you to participate in this surveillance. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent CRO may monitor this surveillance and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.
If you agree to participate in the said surveillance, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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