Comparative Evaluation of Efficacy and safety of clotrimazole versus Fluconazole in the management of Otomycosis

The protocol titled Comparative Evaluation of Efficacy and Safety of Clotrimazole Versus Fluconazole in the Management of Otomycosis A Prospective Randomized Study aims to address a significant clinical gap in the management of otomycosis a frequently encountered superficial fungal infection of the external auditory canal The infection is particularly common in tropical and humid regions and is caused predominantly by Aspergillus and Candida species Patients suffering from otomycosis often experience recurrent symptoms and due to varied success rates of available topical antifungals a consensus on the most effective agent in routine practice remains elusive Thus the present study is intended to rigorously compare the efficacy and side effect profiles of topical clotrimazole and fluconazole ear drops in hopes of facilitating more evidence based therapeutic decisions and improving patient outcomes Subjects eligible for this study are immunocompetent adults between 18 and 60 years of age who present to the ENT outpatient department at AIIMS Bibinagar Hyderabad with clinical features of otomycosis Rigorous inclusion and exclusion criteria will be employed exclusion will be extended to those with tympanic membrane perforation associated otitis media prior usage of topical antifungals and those unwilling to comply with study protocols Upon obtaining written informed consent 100 eligible patients will be randomized into two groups using a block randomization technique with concealed allocation Group A will receive clotrimazole 1 ear drops and Group B will be administered fluconazole 03 ear drops thrice daily for a duration of three weeksA comprehensive baseline assessment will be conducted consisting of otoscopic examination clinical evaluation and microbiological testing of ear swabs by KOH mount and fungal cultures Participants will be evaluated weekly for four weeks with extended follow up at one two and three months post treatment Symptom improvement will be systematically documented using validated scales and mycological clearance will be confirmed through laboratory protocols Both efficacy and treatment emergent side effects will be monitored meticulously Every measure will be taken to maximize patient comfort and maintain confidentiality minimizing risks by employing standard and proven topical therapies Any adverse events occurring during the study will be managed appropriately and without financial burden to the participant The primary objective is to discern whether either clotrimazole or fluconazole leads to superior symptomatic and mycological cure rates for otomycosis Secondary objectives include the assessment of treatment safety and identification of adverse effects related to each antifungal agent Data analysis will follow the intention to treat methodology employing robust statistical methods suitable for both categorical and continuous variables The anticipated benefits for study participants include rapid symptom relief and lower recurrence rates with the overarching community benefit of refining treatment standards for otomycosis Importantly there are no reported conflicts of interest or commercial stakes Adherence to all applicable national ethical and regulatory guidelines including those set forth by ICMR and GCP is assured In conclusion this protocol aims to provide pivotal practice changing data regarding the two most commonly employed antifungal treatments for otomycosis It has been designed to ensure scientific validity ethical rigor and patient safety The results will be communicated via peer reviewed publication and other appropriate forums thereby serving both academic and clinical communities Participants privacy and rights will be protected throughout and if successful the study may inform standard of care protocols for otomycosis at both national and global levels