drugset / Trial / NCT02019446
Laser Treatment for Onychomycosis in Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
Fungal infections of the toe affect one in three people with diabetes. Current treatments for fungal toe infections include oral medications, but these drugs often interact with other common medications. We are studying a new treatment for fungal toe infections involving the use of a laser device. We will compare to the standard treatment which is a type of antifungal medication. This laser has been tested in small numbers of patients with minimal side effects. There will be 60 participants selected for our study, of which 30 will receive standard treatment and the rest will receive laser treatment.
Timeline
- Start
- 2018-07
- Primary completion
- 2020-12
- Completion
- 2021-12
Publications
- Background Ledon JA, Savas J, Franca K, Chacon A, Nouri K. Laser and light therapy for onychomycosis: a systematic review. Lasers Med Sci. 2014 Mar;29(2):823-9. doi: 10.1007/s10103-012-1232-y. Epub 2012 Nov 20.
- Background Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.
- Background Zhang RN, Wang DK, Zhuo FL, Duan XH, Zhang XY, Zhao JY. Long-pulse Nd:YAG 1064-nm laser treatment for onychomycosis. Chin Med J (Engl). 2012 Sep;125(18):3288-91.
- Background Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Terbinafine | Small molecule | — | Topical |