Comparative Study of Traditional Ablative CO2 Laser-Assisted Topical Antifungal with only Topical Antifungal for Treating Onychomycosis: A Multicenter Study
- 20 April 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Clinical Drug Investigation
- Vol. 40 (6), 575-582
- https://doi.org/10.1007/s40261-020-00914-6
Abstract
Background The predominance of onychomycosis has been increasing recently. New medications and treatment modalities are being researched for better saturation of the antifungal agents through the nail plate topically because of the low resilience of some patients for the oral antifungal agents. Treatment of onychomycosis, mainly moderate to severe, can be very challenging, expensive, and time consuming. Objective The objective of this clinical trial is to compare the efficacy and safety of a manually operated ablative CO2 laser combined with a topical antifungal agent in patients with onychomycosis. Study Design We conducted an open-label controlled prospective study of 160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai. It was a 6-month study where both groups were treated with a topical antifungal agent, with the treatment group also receiving ablation by the traditional CO2 laser once a month for the first 3 months. Results The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group. Three (3.75%) patients from the control group and 18 (25%) patients from the treatment group achieved complete nail clearance along with negative potassium hydroxide and negative culture (primary endpoint) results at 24 weeks. Mycological clearance with at least moderate nail clearance (secondary endpoint) for the treatment group was also significantly higher (p < 0.001) for the laser treatment group. The laser treatment was mildly painful but tolerable by the patients. No drug interactions for both groups were encountered. Conclusions The ablative CO2 laser is a primitive yet effective modality to be considered for the delivery of topical antifungal agents for the management of mild-to-severe onychomycosis. The laser has good tolerance in patients and is a common equipment found in most dermatology units even those without the latest medical technology.Funding Information
- Shanghai Shen Kang Hospital Development Center (16CR4034A)
This publication has 30 references indexed in Scilit:
- Translational medicine in the field of ablative fractional laser (AFXL)-assisted drug delivery: A critical review from basics to current clinical statusJournal of the American Academy of Dermatology, 2016
- Fractional carbon-dioxide (CO2) laser-assisted topical therapy for the treatment of onychomycosisJournal of the American Academy of Dermatology, 2016
- Onychomycosis due to opportunistic moldsAnais Brasileiros de Dermatologia, 2015
- Aspergillus species: An emerging pathogen in onychomycosis among diabeticsIndian Journal of Endocrinology and Metabolism, 2015
- Feasibility of ablative fractional laser-assisted drug delivery with optical coherence tomography.Biomedical Optics Express, 2014
- Toenail onychomycosis treated with a fractional carbon-dioxide laser and topical antifungal creamJournal of the American Academy of Dermatology, 2014
- Análisis del polimorfismo genético de los loci HLA-B y HLA-DR en pacientes con onicomicosis dermatofítica y familiares en primer gradoActas Dermo-Sifiliograficas, 2012
- Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild‐to‐moderate toenail onychomycosis: results from three randomized studies using double‐blind vehicle‐controlled and open‐label active‐controlled designsJournal of the European Academy of Dermatology and Venereology, 2011
- Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laserJournal of Cosmetic and Laser Therapy, 2011
- Review of antifungal therapy and the severity index for assessing onychomycosis: Part IJournal of Dermatological Treatment, 2008