Abstract | BACKGROUND: A new 8% ciclopirox-medicated nail lacquer (P-3051), based on a new technology, revealed superior properties in terms of affinity to keratin, nail permeation, and ease of use. OBJECTIVE: This study aims to assess the efficacy and safety of P-3051 vs. the market 8% ciclopirox nail lacquer. METHODS: This is a multicentre, randomized, three-arm, placebo-controlled, parallel groups, evaluator-blinded study. Overall, 467 patients with onychomycosis of at least one big toenail were randomized to receive P-3051, the reference drug or placebo in a 2 : 2 : 1 ratio for a 48-week treatment by daily application, followed by a 12-week follow-up. RESULTS: The study satisfied its objective by demonstrating that P-3051 was both superior to placebo and non-inferior to reference in the complete cure rate after a 48-week active treatment period. Switching the non-inferiority to superiority hypothesis, the superiority of P-3051 vs. reference was nearly significant at week 48 (confirmed at week 52), and it was significant at week 60 (cure rate for P-3051 is 119% higher than reference; P < 0.05). Altogether, the results on primary endpoint exceed expectations; superiority test was performed also on secondary endpoints to confirm the superiority trend of the study. At the end of follow-up, percentages of patients who achieved the endpoint 'responder' in the P-3051 group were 66% higher than reference (P < 0.05), and those who achieved the endpoint 'decrease of diseased nail' were 40% higher (P < 0.05). CONCLUSION:
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Authors | R Baran, A Tosti, I Hartmane, P Altmeyer, J Hercogova, V Koudelkova, T Ruzicka, P Combemale, I Mikazans |
Journal | Journal of the European Academy of Dermatology and Venereology : JEADV
(J Eur Acad Dermatol Venereol)
Vol. 23
Issue 7
Pg. 773-81
(Jul 2009)
ISSN: 1468-3083 [Electronic] England |
PMID | 19453778
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antifungal Agents
- Biopolymers
- Placebos
- Pyridones
- Water
- Ciclopirox
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Topics |
- Adult
- Antifungal Agents
(administration & dosage, adverse effects, therapeutic use)
- Biopolymers
(administration & dosage)
- Ciclopirox
- Female
- Humans
- Male
- Middle Aged
- Onychomycosis
(drug therapy)
- Placebos
- Pyridones
(administration & dosage, adverse effects, therapeutic use)
- Solubility
- Treatment Outcome
- Water
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