Red-Laser Photodynamic Therapy with Toluidine Blue Gel as an Adjuvant to Topical Antifungal Treatments for Onychomycosis in Patients with Diabetes: A Prospective Case Series

<b>Background</b>: Systemic therapy is frequently utilized because of its easy accessibility, low cost, and high efficacy. However, it can be linked with systemic adverse effects and drug-drug interactions, especially in immunocompromised and poly-medicated patients. Topical antifungals, associated with a low risk of systemic adverse effects and drug-drug interactions, have emerged as the most suitable treatment option for patients with diabetic foot disease. However, the duration of topical treatment can extend up to 12 months. Consequently, there is a need to bolster these topical treatments with complementary therapies. <b>Methods</b>: The current study acquired approval from an ethics committee (code 24/241-E) and Clinical Trials (code NCT06485050). No patients were excluded, irrespective of comorbidities or the severity of onychomycosis. Patients included in the study were administered Ciclopirox 8% (consisting of ethyl acetate, 96% ethanol, ketostearyl alcohol, hydroxypropyl chitosan, and purified water) once daily for 6 months. This was supplemented with photodynamic therapy (three sessions in the first 2 months) using toluidine blue gel and a 635 nm diode laser lasting 10 min, as well as monthly debridement of the nail plate. <b>Results</b>: All patients (10/10) included in the study exhibited negative microbiological culture results 6 months after the study began. Of these, 90% (9/10) were clinically cured, and thus, fully cured. No adverse effects or complications secondary to the treatments were observed in any of the cases. The average Onychomycosis Severity Index (OSI) value was initially 18.50 ± 8.947, reduced to 10.30 ± 6.129 at 3 months, and finally fell to 4.10 ± 4.08 at the end of the treatment. <b>Conclusions</b>: The current study demonstrated the clinical improvement, mycological cure, effectiveness, and safety of combination therapy of ciclopirox 8% and photodynamic therapy over 6 months.