Antonella Tosti1, Bom E Elewski2. 1. Department of Dermatology & Cutaneous Surgery, Leonard Miller School of Medicine, University of Miami, Miami, Florida; 2. Department of Dermatology, University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama.
Abstract
OBJECTIVE: To evaluate the benefits of efinaconazole topical solution, 10% on quality of life in onychomycosis patients. METHODS: An analysis of 1,655 patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled, 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture); clinical improvement defined as ≤ 10-percent improvement in nail involvement both at Week 52. Quality of life was assessed using a validated OnyCOE-t™ questionnaire. Improvement in quality of life was compared in those patients clinically and not clinically improved. RESULTS:Efinaconazole topical solution, 10%, was significantly more effective than vehicle irrespective of QoL domain. Greatest improvement in mean score was seen in those domains with the lowest baseline scores. All mean scores in the group considered to have clinically improved with efinaconazole exceeded 80.0 at Week 52. Mean treatment satisfaction scores with efinaconazole in those patients who were clinically improved increased from 79.9 (Week 24) to 89.2 (Week 52), compared to a corresponding drop in those patients considered not improved from 65.3 to 58.0. The correlation between change in percent affected nail and change in mean domain scores was significant with efinaconazole for all domains. LIMITATIONS: A period of 52 weeks may be too brief to evaluate improvement in quality of life in onychomycosis patients. Some of the questions in the OnyCOE-t questionnaire may be more relevant than others to the study population and the onychomycosis population as a whole. CONCLUSION: Once-daily efinaconazole topical solution, 10%, provided statistically greater improvement in all aspects of quality of life compared to vehicle. Improvement was most marked in those patients considered clinically improved and correlated with a change in percent affected nail.
RCT Entities:
OBJECTIVE: To evaluate the benefits of efinaconazole topical solution, 10% on quality of life in onychomycosispatients. METHODS: An analysis of 1,655 patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled, 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture); clinical improvement defined as ≤ 10-percent improvement in nail involvement both at Week 52. Quality of life was assessed using a validated OnyCOE-t™ questionnaire. Improvement in quality of life was compared in those patients clinically and not clinically improved. RESULTS:Efinaconazole topical solution, 10%, was significantly more effective than vehicle irrespective of QoL domain. Greatest improvement in mean score was seen in those domains with the lowest baseline scores. All mean scores in the group considered to have clinically improved with efinaconazole exceeded 80.0 at Week 52. Mean treatment satisfaction scores with efinaconazole in those patients who were clinically improved increased from 79.9 (Week 24) to 89.2 (Week 52), compared to a corresponding drop in those patients considered not improved from 65.3 to 58.0. The correlation between change in percent affected nail and change in mean domain scores was significant with efinaconazole for all domains. LIMITATIONS: A period of 52 weeks may be too brief to evaluate improvement in quality of life in onychomycosispatients. Some of the questions in the OnyCOE-t questionnaire may be more relevant than others to the study population and the onychomycosis population as a whole. CONCLUSION: Once-daily efinaconazole topical solution, 10%, provided statistically greater improvement in all aspects of quality of life compared to vehicle. Improvement was most marked in those patients considered clinically improved and correlated with a change in percent affected nail.
Authors: C Seebacher; J Brasch; D Abeck; O Cornely; I Effendy; G Ginter-Hanselmayer; N Haake; G Hamm; U-Ch Hipler; H Hof; H C Korting; P Mayser; M Ruhnke; K-H Schlacke; H-J Tietz Journal: Mycoses Date: 2007-07 Impact factor: 4.377
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