Bhavana Rajbanshi1, Liangliang Shen1, Miao Jiang1, Qingyu Gao1, Xin Huang1, Jiaoyang Ma2, Jihong Wang3, Yang Hu4, Hongli Lv5, Xiao Wu1, Jingjun Zhao6. 1. Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China. 2. Department of Dermatology and Venereology, Putuo District Central Hospital, Shanghai, China. 3. Department of Dermatology and Venereology, Jiading District Anting Hospital, Shanghai, China. 4. Department of Dermatology and Venereology, Jiading District Nanxiang Hospital, Shanghai, China. 5. Department of Dermatology and Venereology, Jiading District Central Hospital, Shanghai, China. 6. Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China. zhaojingjun2015@aliyun.com.
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.
RCT Entities:
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.
Authors: D M L Saunte; B M Piraccini; A Y Sergeev; A Prohić; B Sigurgeirsson; C Rodríguez-Cerdeira; J C Szepietowski; J Faergemann; M Arabatzis; M Pereiro; M Skerlev; P Lecerf; P Schmid-Grendelmeier; P Nenoff; R J Nowicki; L Emtestam; R J Hay Journal: J Eur Acad Dermatol Venereol Date: 2018-12-13 Impact factor: 6.166
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