Among patients with diabetes who are at increased risk of developing foot ulcers, laser therapy for onychomycosis was safe but not effective, according to a study published in the Journal of the European Academy of Dermatology and Venereology.
Researchers of this randomized, quadruple-blind, sham-controlled study (ClinicalTrials.gov identifier: NCT01996995) evaluated the efficacy, cure rate, and safety of laser therapy for onychomycosis among such patients, including those who were diagnosed with diabetes, had a Sims classification score of 1 or 2, and a clinical suspicion of onychomycosis. Laser therapy included 4 sessions of neodymium-doped yttrium aluminium garnet 1064nM laser or sham treatment (ie, active treatment). Pictures and samples of nails were taken from patients enrolled in the study prior to treatment and at 52-week follow-up appointments.
Of the 63 patients included in the analysis, 34% were women, 80% had type 2 diabetes, and the mean age was 68 years old. At baseline, the most common pathogen present on nails was Trichophyton rubrum. After treatment, the microbiological cure was achieved in 41.9% of those assigned to the sham group and 43.8% of those who received laser therapy; nail improvement was shown in 3 patients in the sham group and 7 patients in the active treatment group. Nail involvement improved 9.7% in the sham group and 13% in the active treatment group, and the mean onychomycosis severity index decreased by 3.3% in the sham group and 4.5% in the active treatment group. None of these findings were statistically significant.
Overall, 6 serious adverse events were reported in the active treatment group, 1 serious adverse event was reported in the sham group, and 2 adverse events were reported in the active treatment group.
Limitations of this study include slower than expected nail growth, the inability to evaluate patient’s nail hygiene during the course of the study, and the lower prognostic success rate at baseline.
The researchers concluded that “laser treatment for onychomycosis in patients with diabetes at risk for foot ulcers does not seem to be effective and should be regarded as experimental therapy.”
Disclosure: Leonie Nijenhuis-Rosien reports association with the medical device company that manufactures the laser.
Nijenhuis-Rosien L, Kleefstra N, van Dijk PR, et al. Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: A randomised, quadruple-blind, sham controlled trial (LASER-1) [published online March 28, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15601