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Newly approved laser systems for onychomycosis
Aditya K Gupta1, Fiona Simpson
1Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Canada. agupta@execulink.com
Journal of the American Podiatric Medical Association
|September 25, 2012
Summary
Laser systems offer a new approach for fungal nail infections (onychomycosis). While the FDA has approved several devices, limited trials prevent direct comparison with traditional treatments.
Area of Science:
- Dermatology
- Medical Technology
Background:
- Onychomycosis is a common fungal nail infection.
- Traditional treatments include oral and topical pharmacotherapy.
- Laser systems represent a novel therapeutic modality.
Purpose of the Study:
- To review the current status of FDA-approved laser systems for onychomycosis.
- To discuss the regulatory basis for approval.
- To highlight the need for further clinical evidence.
Main Methods:
- Review of FDA approvals for laser devices for onychomycosis as of January 2012.
- Analysis of the "substantial equivalence" criterion for device approval.
- Literature search for existing clinical trial data.
Main Results:
- Four laser systems were approved by the US FDA for temporary improvement in clear nail for onychomycosis.
- Approval was based on substantial equivalence to predicate devices.
- Clinical trial data supporting efficacy is limited.
Conclusions:
- Laser therapy is a promising alternative for onychomycosis treatment.
- Further robust clinical trials are necessary to compare laser efficacy against established pharmacotherapies.
- The long-term effectiveness and safety profile require additional investigation.
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