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: Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis. Conflicts of interest None declared.
| Original language | English |
|---|---|
| Pages (from-to) | 773-781 |
| Number of pages | 9 |
| Journal | Journal of the European Academy of Dermatology and Venereology |
| Volume | 23 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 1 2009 |
| Externally published | Yes |
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Keywords
- Ciclopirox
- Hydroxypropyl chitosan
- Onychomycosis
- Water-soluble nail lacquer
ASJC Scopus subject areas
- Dermatology
- Infectious Diseases
Cite this
An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis. / Baran, R.; Tosti, Antonella; Hartmane, I.; Altmeyer, P.; Hercogova, J.; Koudelkova, V.; Ruzicka, T.; Combemale, P.; Mikazans, I.
In: Journal of the European Academy of Dermatology and Venereology, Vol. 23, No. 7, 01.07.2009, p. 773-781.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis
AU - Baran, R.
AU - Tosti, Antonella
AU - Hartmane, I.
AU - Altmeyer, P.
AU - Hercogova, J.
AU - Koudelkova, V.
AU - Ruzicka, T.
AU - Combemale, P.
AU - Mikazans, I.
PY - 2009/7/1
Y1 - 2009/7/1
N2 - 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: Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis. Conflicts of interest None declared.
AB - 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: Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis. Conflicts of interest None declared.
KW - Ciclopirox
KW - Hydroxypropyl chitosan
KW - Onychomycosis
KW - Water-soluble nail lacquer
UR - http://www.scopus.com/inward/record.url?scp=66749106212&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=66749106212&partnerID=8YFLogxK
U2 - 10.1111/j.1468-3083.2009.03164.x
DO - 10.1111/j.1468-3083.2009.03164.x
M3 - Article
C2 - 19453778
AN - SCOPUS:66749106212
VL - 23
SP - 773
EP - 781
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
SN - 0926-9959
IS - 7
ER -