Recent Research Shows The Failure Of Laser Therapy As A Monotherapy For Onychomycosis

When people ask my opinion on laser therapy for toenail onychomycosis, I state something along the lines of: “The studies are poorly done,” “The evidence is weak” and/or “I wouldn’t recommend it as monotherapy.” When the laser boom was occurring in our profession, I would get inundated by patients who believed the laser was the magic bullet to end the dermatophyte invasion in the nail unit.

As we all know, there is no antifungal therapy or device that gives us a 100 percent mycological cure and/or clinical cure, and it certainly can’t occur overnight or even in a month’s time from a physiological perspective. What we currently have is a range of oral and topical antifungals that researchers have studied in a setting appropriate for Food and Drug Administration (FDA) approval for treatment of the fungal infection. Device approval from the FDA is a different animal from pharmacological approval. The FDA statement for laser devices for onychomycosis is: “temporary increase of clear nail in patients with onychomycosis.” If you used laser therapy and only laser therapy (no orals or topicals given concomitantly, even the OTC agents), how many of your patients wanted to convert to something else or were dissatisfied? 

Researchers recently examined the use of a short pulsed 1064 nm Nd:YAG (PinPointe Footlaser, NuvoLase) laser for onychomycosis in a prospective, randomized, controlled study.¹ The study involved 20 patients with 82 mycotic nails who had positive fungal cultures for T. rubrum. The patients either received laser therapy (four treatments in four- to six-week intervals) or no laser treatment. Both patient groups were allowed amorolfine (a topical antifungal available in Europe) use in between the toes and plantarly for the duration of the study period. The study authors also noted that debridement of all affected nails prior to treatment. Researchers assessed patients 12 months after the final laser treatment for mycological cure and utilized photographs to assess the Onychomycosis Severity Index (OSI).

What were the results? No patient achieved a mycological cure at 12 months.  Visually, the Onychomycosis Severity Index worsened by 2 points in the laser group and 3.6 points in the no laser treatment group. The study’s ultimate conclusion: monotherapy with this particular laser resulted in neither mycological nor visual improvement. 

There was a 12-month follow-up period with this study. As we all know, recurrence is high for this nail disease. In this case, four laser treatments with nothing else besides a topical antifungal (for skin, not the nails) and review of foot hygiene did not yield long-lasting results. 

Of course, there were aspects of the study that researchers could have approached differently. They should not have used a topical antifungal for the skin and there was inconsistent infected nail involvement (i.e. all nails in the study had mild to severe infection instead of the range of mild to moderate which is customarily studied). Overall, though, it is, at long last, the study I have been waiting for.

Ultimately, this study shows that laser is not a reliable monotherapy for onychomycosis treatment. Could lasers have a role as adjuvant therapy with either oral or topical antifungals? It certainly is a research question that warrants further investigation. 

Reference

1. Karsai S, Jäger M, Oesterhelt A, et al. Treating onychomycosis with the short-pulsed 1064-nm-Nd:YAG laser: results of a prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2016; epub Aug 13.