A randomized trial of XXXX 5% solution nail lacquer in association with @entity2059 pulse therapy compared with @entity2059 alone in the treatment of Candida fingernail @entity6313 .

@entity1 @entity12364 @entity6313 @entity7409 @entity5132 @entity7634 @entity20517 @entity2059
BACKGROUND: Treatment failures and relapses are not uncommon in @entity6313 . Therefore, it is worthwhile to consider the combination of systemic and topical antifungals to improve the cure rates further and to reduce the duration of systemic treatment. OBJECTIVES: To evaluate and compare @entity2059 pulse therapy combined with @entity20517 with @entity2059 alone in the treatment of Candida fingernail @entity6313 . METHODS: Ninety @entity1 with moderate to severe Candida fingernail @entity6313 were randomized into two treatment groups of 45 subjects each. Group 1 received @entity2059 pulse therapy for 2 months and applied @entity20517 5% solution nail lacquer for 6 months, while group 2 received monotherapy with three pulses of @entity2059 . The primary efficacy criterion was the result of mycological examination at 3 months. The secondary criterion was the combined mycological and clinical response at 9 months. A pharmacoeconomic analysis was also performed to compare the cost-effectiveness of combined therapy vs. monotherapy. RESULTS: Eighty-five @entity1 were analysed (73 @entity1 and 12 @entity1 , mean +/- SD age 44.2 +/- 12.9 years). @entity1 had a mean +/- SD of 3.64 +/- 2.0 nails involved and 228.6 +/- 148.0 mm2 of their nail surface diseased. The mean duration of @entity6313 was 11 months. Paronychial involvement was evident in 71 @entity1 . @entity5132 was isolated in 85 cases, @entity7409 in three and other Candida species in two cases. Side-effects were uncommon and in only one case led to withdrawal. At the 3-month visit, mycological cure was seen in 32 (74%) of 43 @entity1 in group 1 and in 25 (60%) of 42 @entity1 in group 2. At the 9-month visit, a global cure was seen in 40 @entity1 (93%) in group 1 and in 34 @entity1 (81%) in group 2. Statistical analysis showed no statistically significant difference (P > 0.1) between the two treatment groups. The cost per cure ratio was 1.63 and 1.70 @entity7634 for groups 1 and 2, respectively. CONCLUSIONS: The combination of @entity20517 and oral @entity2059 , which interfere with different steps of @entity12364 synthesis, exhibited substantial synergy. Compared with oral @entity2059 alone, the combination achieved greater mycological cure and increased total cure rate. However, no statistically significant difference was documented for this number of observations. Combination treatment with @entity20517 and two pulses of @entity2059 is at least as safe and effective as three pulses of @entity2059 , with a lower cost per @entity1 . In our opinion, the addition of @entity20517 to oral @entity2059 pulse therapy is of value in the treatment of moderate to severe Candida fingernail @entity6313 .
