INTRODUCTION
Onychomycosis is a fungal infection of the nail plate and subungual area, with a high global incidence of 2–18%.1 Most treatment is with topical or oral administration of antifungal agents. Topical antifungal agents have difficulty in penetrating the nail plate and reaching the nail bed, thus, prolonged treatment and poor efficacy might be expected.2 Oral antifungal agents may be associated with hepatorenal impairment and patient compliance is generally poor. Therefore, the treatment of onychomycosis is challenging.3 Long-pulsed Nd:YAG 1064 nm laser intervention with ClearSteps (Fotona, Germany) is approved by the US Food and Drug Administration, and its favorable efficacy and safety profiles have been thoroughly investigated.4-6 However, the regimen for laser intervention against onychomycosis has not been fully established. The course of treatment for oral antifungal agents against toenail onychomycosis is longer than that of fingernail onychomycosis.7,8 Thus, we proposed that there might be differences in the course of laser intervention and recovery between toenail and fingernail onychomycosis. To evaluate the efficacy and safety of ClearSteps for onychomycosis patients in China and improve the laser intervention regimen against onychomycosis, 37 patients with 50 fingernails, and 62 toenails affected by onychomycosis were treated with ClearSteps, and 39 patients with 118 affected nails were treated with oral itraconazole, and were followed up for 24 weeks.
METHODS
Inclusion and Exclusion Criteria
Patients were included if they met the following inclusion criteria: age 18–75 years; typical clinical manifestations of onychomycosis; positive results of direct microscopic examination; and provided informed consent. They were also asked to attend follow-up as scheduled. The patients enrolled should not have received any topical antifungals within 1 month and oral antifungals within 6 months of enrollment. The Scoring Clinical Index of Onychomycosis (SCIO)9 was estimated to be 6–15 points, in response to Grade II–IV disease.
The exclusion criteria included: patients who discontinued the treatment spontaneously; had a regimen switch during the study or loss to follow-up; patients who received other antifungal drugs or other drugs that might have affected efficacy of laser treatment; patients with continuous or semicontinuous nail discoloration, including fingernail pigmentation abnormalities for therapeutic or cosmetic purposes, such as topical application of antifungal solution Castellany, Nail Stains, polishing agent (containing magnesium or iron components) or occupational exposure to dye or asphalt UML; patients receiving a photosensitizer within 6 months of enrollment; pregnant women; patients with subungual hematoma or mole-like tissue formation; and patients with nail changes concomitant with other disorders, such as nail plate psoriasis, lichen planus, and
