Effectiveness of Black Peel with 1% Clotrimazole Cream vs Oral Terbinafine in the Treatment of Onychomycosis-Randomized Controlled Trial

Background: Onychomycosis accounts for 90% of all the toe nail infections and 30 % of all cutaneous fungal infections.(1) The management of this disease is challenging, as on one end there is increasing evidence of growing fungal resistance against available antifungals; and on the other end the majority of the effected individuals are old aged and have comorbidities limiting the use of systemic treatment in such cases.(2) In such circumstances there is an increasing need for exploring newer treatment options for onychomycosis. The aim of the study was to compare the effectiveness of topical back peel combined with 1% clotrimazole versus oral terbinafine in cases of onychomycosis. We hypothesized that this topical combination strategy is better than oral terbinafine in this disease. We carried out a randomized clinical trial in the Dermatology OPD of our tertiary care hospital in Pakistan over a period of 06 months i.e., from March to August 2024. Methods: 90 patients suffering from onychomycosis meeting our inclusion criteria were included in the study after informed consent. Later on, six patients were dropped due to non-compliance issues. Sampling was done by non-probability randomized sampling. Group A was treated by weekly black peel combined with daily 1% clotrimazole cream for 3 months and group B was treated by oral terbinafine 250mg for 03 months. After 03 months of treatment, results were analyzed by observing the change in mean onychomycosis severity index (OSI) and patient satisfaction scores. Results: There was lesser OSI in group B (1.43±2.25) as compared to group A (5.32±6.5) after treatment with significant p value of o.oo3. The mean difference between the groups was 3.887±1.08. But within each group there was a significant difference in pre-treatment to post treatment OSI (p=<0.001 in each group). Conclusion: Black peeling combination with topical 1% clotrimazole is a comparable treatment option to oral terbinafine for the treatment of onychomycosis.