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Itraconazole (ITZ) has been the mainstay of oral antifungal treatment for the current epidemic of recalcitrant dermatophytosis (RD) in India. Recently, a newer formulation of ITZ, super bioavailable itraconazole (SUBA-ITZ), is made available in the market by many pharmaceutical companies. It is important for dermatologists to understand the pharmacokinetic properties of SUBA-ITZ vis-a-vis conventional pellet formulation to use it effectively and safely. Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) has established a special interest group for recalcitrant dermatophytosis (SIG-RD) to strengthen research, continuing medical education, and industry collaboration on the subject. This position statement on SUBA-ITZ by SIG-RD is an attempt to address current pieces of evidence and the position of this new formulation in the management of RD. [ABSTRACT FROM AUTHOR]

Background: The present epidemic of dermatophytosis in India is marked by an increase in chronic, recurrent and disseminated cases. A combination of oral itraconazole and topical luliconazole is being increasingly utilised by dermatologists in India. The superiority of this combination is not supported by robust clinical trial data. Objective: We conducted this randomised, open-label, two arms, parallel assignment intervention trial between November 2022 and May 2023 to determine the superiority of topical 1% Luliconazole over bland emollient as adjuvant to systemic Itraconazole therapy in the management of dermatophytosis. Method: In this study, 135 patients of either sex were randomised to two study cohorts. Major exclusions being concomitant medical illness, use of concomitant medication and substance abuse. Participants were randomly assigned to receive topical bland emollient, (Cohort I, n = 67) or topical luliconazole, (Cohort II, n = 68). Both cohorts received oral itraconazole 200 mg/day (100 mg BID) and levocetirizine 5 mg twice a day as a systemic regime. Clinical and mycological cure at the end of 6 weeks and clinical relapse among cure patients during 10-week follow-up were observed. Results: The cure rates for Cohorts I and II at 6 weeks were 50 (74.62%) and 56 (82.35%), (p = .46), respectively. During the 4-week follow-up period, clinical relapses were observed in 16 (32%) of the 50 patients in Cohort I and 12 (21.43%) of the 56 patients in Cohort II (p = .18). Luliconazole cohort shows a significantly higher medical cost (p < .05). Conclusion: Our study shows a similar cure rate and relapse rate for patients receiving topical Luliconazole versus topical bland emollient as an adjuvant to the systemic itraconazole regime. [ABSTRACT FROM AUTHOR]

Competing Interests: Conflicts of interest None declared.

Itraconazole (ITZ) has been the mainstay of oral antifungal treatment for the current epidemic of recalcitrant dermatophytosis (RD) in India. Recently, a newer formulation of ITZ, super bioavailable itraconazole (SUBA-ITZ), is made available in the market by many pharmaceutical companies. It is important for dermatologists to understand the pharmacokinetic properties of SUBA-ITZ vis-a-vis conventional pellet formulation to use it effectively and safely. Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) has established a special interest group for recalcitrant dermatophytosis (SIG-RD) to strengthen research, continuing medical education, and industry collaboration on the subject. This position statement on SUBA-ITZ by SIG-RD is an attempt to address current pieces of evidence and the position of this new formulation in the management of RD., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Indian Dermatology Online Journal.)

Competing Interests: There are no conflicts of interest.

Introduction: In the present epidemic of chronic, recalcitrant, and widespread dermatophytosis, impact of disease on quality of life (QoL) can be severe. Similarly, financial impact due to treatment cost and loss of wages needs consideration too., Aims and Objectives: Our primary aim was to evaluate the impact of dermatophytosis on QoL and the financial burden on individual and family., Materials and Methods: Adult patients having dermatophytosis were included in the study. Standard Dermatology Life Quality Index (DLQI) questionnaire was used to evaluate the psychosocial impact, and financial burden was evaluated by nine binary questions., Results: A total of completed 299 DLQI surveys and 275 financial burden surveys were taken for final analysis. Mean DLQI was 12.25 (SD = 5.56, n = 299). Significant association between total body surface area (BSA) and DLQI score was observed ( r s = 0.251 , P < 0.001, n = 299). Presence of tinea corporis was found to be significantly affecting the choice of clothing ( P = 0.018, χ 2 = 5.127, CI 95%). More numbers of male respondents reported loss of work or study hours due to their illness ( P = 0.015, χ 2 = 5.196, CI 95%), which was significantly associated with the BSA involved ( P < 0.05, t = 5.529, CI 95%). Some difficulties in sexual activity were reported by 35.6% patients, which has significant association with tinea cruris ( P = 0.001, χ 2 = 10.810, CI 95%). Median household income was 10,000 INR and interquartile range (IQR) being 8,000-19,000. Mean financial burden calculated at 3.458 (SD = 1.696, n = 275), whereas mean financial worry reported by patient stood at 3.661 (SD = 1.216, n = 275). Financial burden showed significant correlation with "previous treatment approximate cost," financial worry, and DLQI ( P < 0.05, CI 95%). Financial worry ( P = 0.016, r s = 0.145, CI 95%) and financial burden ( P = 0.002, r s - = 0.145 , CI 95%) both showed positive correlation with duration of disease., Conclusion: In present scenario of Dermatophytosis in India, the disease and its treatment causing impact on QOL as well as on personal financial burden and worry need consideration., Competing Interests: There are no conflicts of interest., (Copyright: © 2020 Indian Dermatology Online Journal.)

Competing Interests: There are no conflicts of interest.