Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.

What this Trial Is About

Researchers are evaluating treatment options for patients with onychomycosis, a fungal nail infection. This randomized controlled trial compares itraconazole alone with itraconazole combined with either low dose isotretinoin or excimer light. The study aims to assess the effectiveness of these combinations in improving clinical outcomes for onychomycosis over six months. Participants will be divided into three groups: one receiving itraconazole 200 mg twice daily for one week each month over three months; a second group receiving the same itraconazole treatment plus low dose isotretinoin 20 mg every other day for three months with an additional 4-6 weeks of maintenance dosing; and a third group receiving itraconazole plus excimer light therapy applied to the nails using the XeCl2 excimer light device. All treatments begin after screening blood tests to ensure safety. Participants will undergo clinical assessments and fungal cultures at the start, monthly during treatment, at the end of treatment, and three months post-treatment, totaling six months of follow-up. The severity of onychomycosis will be graded using the Onychomycosis Severity Index. Blood tests and patient-reported side effects will be monitored. The main outcomes measured are clinical improvement and fungal culture results to evaluate treatment response and durability.

Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis