Dermatologic surgery
Lack of efficacy with 1064-nm neodymium:yttrium-aluminum-garnet laser for the treatment of onychomycosis: A randomized, controlled trial

https://doi.org/10.1016/j.jaad.2013.12.024Get rights and content

Background

Laser therapies have been Food and Drug Administration approved for temporary nail plate clearance; however, there is minimal evidence of their long-term efficacy.

Objective

We sought to evaluate the clinical and mycological clearance of toenails treated with 1064-nm neodymium:yttrium-aluminum-garnet laser versus no treatment.

Methods

This was a randomized, controlled, single-center trial comparing 2 treatments with 1064-nm neodymium:yttrium-aluminum-garnet laser (fluence of 5 J/cm2, rate of 6 Hz) spaced 2 weeks apart versus no treatment in 27 patients (N = 125 affected nails) with clinical and mycological diagnosis of onychomycosis. At 3 months, patients were assessed with mycological cultures and proximal nail plate measurements. Patients treated with laser were also assessed with proximal nail plate measurements at 12 months.

Results

At 3 months, 33% of patients treated with laser achieved a negative mycological culture compared with 20% of the control group (P = .49), and had more proximal nail plate clearance compared with control subjects (0.44 vs 0.15 mm, P = .18), which was not statistically significant. At 12 months, there was no difference in nail plate clearance between laser versus control subjects (0.24 vs 0.15 mm, P = .59).

Limitations

Our study was limited by the small sample size and number of treatments.

Conclusions

There was no significant mycological culture or clinical nail plate clearance with 1064-nm neodymium:yttrium-aluminum-garnet laser compared with control.

Section snippets

Methods

The study was a randomized, controlled trial conducted at a single academic institution. The primary end point for the study was the percentage of patients with a negative mycological culture from all clinically involved nails at 3 months, and the secondary end point was the difference in clinical proximal nail plate clearance at 3 months and at 12 months. An additional secondary end point was the number of nails with complete clinical nail plate clearance at 3 months and, for laser patients,

Results

In all, 42 patients were assessed for eligibility (Fig 1). Fifteen patients were excluded because of lack of positive mycological culture. The remaining 27 patients were randomized in a 2:1 ratio into laser (N = 17) and control (N = 10) groups. Five of the patients in the laser group did not return for follow-up, with 12 of patients in this group completing the study, whereas all of the patients in the control group completed the study. The 12 patients in the laser group exhibited 57 clinically

Discussion

We performed a randomized controlled trial of 1064-nm Nd:YAG laser treatment for onychomycosis. We found that 1064-nm Nd:YAG laser treatment did not improve mycological culture or long-term proximal nail plate clearance (Fig 3). Similar to other studies, we detected a trend of improved proximal nail plate clearance at 3 months, but this clearance did not persist at 12 months. Our study supports the recent in vitro findings by Hees et al14 who treated fungal colony isolates in a Petri dish with

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    The JOULE ClearSense handpiece was loaned to Stanford Department of Dermatology from Sciton Inc for the purposes of the study.

    Conflicts of interest: None declared.

    Reprints not available from the authors.

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