2012
DOI: 10.1590/s0365-05962012000100002
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Comparative clinical evaluation of efficacy and safety of a formulation containing ciclopirox 8% in the form of a therapeutic nail lacquer in two different posologies for the treatment of onychomycosis of the toes

Abstract: BACKGROUND: The use of topical antifungal agents in the treatment of onychomycosis is of great value in clinical practice as there are different limitations regarding the use of systemic treatment. OBJECTIVE: To evaluate the efficacy and safety of a nail lacquer formulation containing ciclopirox 8% in two different posologies: the traditional regimen (3/2/1) and a regimen of weekly use. METHODS: A blind, randomized, comparative trial which included 41 patients divided into 02 groups, with Group I using the nai… Show more

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Cited by 8 publications
(6 citation statements)
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“…For clinical trials including only DLSO toenails, mycologic cure rates varied between 74 and 92% for terbinafine, 38,43,54-57 between 61 and 100% for pulse itraconazole, 38,45,54,57-59 69% for continuous itraconazole, 58 between 31 and 67% for fluconazole, 38,40,54,60,61 between 53 and 87% for efinaconazole, 8,35 and between 34 and 70% for ciclopirox. 62,63 One study investigating the efficacy of terbinafine alone or combined with ciclopirox reported significantly different mycologic rates between PSO (1 of 4 = 25%) and DLSO (42 of 54 = 78%) or SO (9 of 10 = 90%). 32 Unfortunately, the authors did not specify the treatment received by the successful cured case of PSO.…”
Section: Treatment Choice Based On Clinical Presentationmentioning
confidence: 99%
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“…For clinical trials including only DLSO toenails, mycologic cure rates varied between 74 and 92% for terbinafine, 38,43,54-57 between 61 and 100% for pulse itraconazole, 38,45,54,57-59 69% for continuous itraconazole, 58 between 31 and 67% for fluconazole, 38,40,54,60,61 between 53 and 87% for efinaconazole, 8,35 and between 34 and 70% for ciclopirox. 62,63 One study investigating the efficacy of terbinafine alone or combined with ciclopirox reported significantly different mycologic rates between PSO (1 of 4 = 25%) and DLSO (42 of 54 = 78%) or SO (9 of 10 = 90%). 32 Unfortunately, the authors did not specify the treatment received by the successful cured case of PSO.…”
Section: Treatment Choice Based On Clinical Presentationmentioning
confidence: 99%
“…Based on our recent systematic review of publications on systemic therapy in children, 87 pediatric and adult populations have similar responses to oral treatments in terms of safety and efficacy; however, the dosing regimens must be readjusted according to the child's weight. 88 Similarly, a mycologic cure rate of 70% has been safely achieved in small trials of topical ciclopirox 8% nail lacquer with dé bridement in both children 89 and adults, 63,90 but ciclopirox is not generally as effective as oral treatments. 31 A subgroup analysis of elderly participants (65-75 years old) in the clinical trials comparing terbinafine with and without débridement showed that a similar mycologic cure rate was obtained for the elderly and participants under 65 years old (OR 0.95, 95% CI 0.57-1.58).…”
Section: Treatment Choice Based On the Age Of The Patientmentioning
confidence: 99%
“…Five RCTs [14,[19][20][21] and one open, noncomparative trial [22] of ciclopirox were evaluated and received quality ratings ranging from 5.5 to 15 out of a possible 20. Five of these trials administered ciclopirox 8 % lacquer daily for 9-12 months, with one trial [21] administering ciclopirox weekly for 6 months (Table 1).…”
Section: Ciclopiroxmentioning
confidence: 99%
“…Application of ciclopirox lacquer was subsequently investigated in a single-blind RCT using a 3/2/1 treatment regimen (three times a week for 1 month, two times a week for the second month, and once a week for months 3-6) and a weekly regimen [21]. Forty-one patients with DSO or LSO without matrix involvement and 10-50 % nail involvement of either great toe were enrolled.…”
Section: Ciclopiroxmentioning
confidence: 99%
“…Ciclopirox, with water-insoluble polymers, is applied on the cleaned nail every second day for the first month, so the active substance penetrates the nail, twice a week for the second month and once a week from the third month on. No statistically significant difference in the drug effectiveness between this sequence and daily application was found, however, in most clinical trials daily application was used [ 39 ]. Once a week ciclopirox should be removed with cosmetic nail remover.…”
Section: Ciclopiroxmentioning
confidence: 99%