An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis

Journal of the European Academy of Dermatology and Venereology

Volumn 23, Issue 7, 2009, Pages 773-781

  Baran, R ^a   Tosti, A ^b   Hartmane, I ^c   Altmeyer, P ^d   Hercogova, J ^e   Koudelkova, V ^f   Ruzicka, T ^g   Combemale, P ^h   Mikazans, I ^c  

^a NAIL DISEASE CENTRE   (France)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c Clinical Centre of Skin and STD   (Latvia)

^d RUHR UNIVERSITY BOCHUM   (Germany)

^e UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

^f UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^g UNIVERSITY OF MUNICH   (Germany)

^h HIA Desgenettes   (France)

Author keywords

Ciclopirox; Hydroxypropyl chitosan; Onychomycosis; Water soluble nail lacquer

Indexed keywords

BIOPOLYMER; CHITOSAN DERIVATIVE; CICLOPIROX; P 3051; PAINT; PLACEBO; UNCLASSIFIED DRUG;

ARTICLE; BINDING AFFINITY; BURNING SENSATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG PROTEIN BINDING; DRUG SAFETY; EDEMA; ERYTHEMA; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ONYCHOMYCOSIS; PAIN; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME;

ADULT; ANTIFUNGAL AGENTS; BIOPOLYMERS; FEMALE; HUMANS; MALE; MIDDLE AGED; ONYCHOMYCOSIS; PLACEBOS; PYRIDONES; SOLUBILITY; TREATMENT OUTCOME; WATER;

EID: 66749106212     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/j.1468-3083.2009.03164.x     Document Type: Article

References (18)

1. Monti D, Saccomani L, Chetoni P, Burgalassi S, Saettone MF, Mailland F. In vitro transungual permeation of ciclopirox from a hydroxypropyl-chitosan- based, water-soluble nail lacquer. Drug Dev Ind Pharm 2005 31 : 11 17. (Pubitemid 40170583)
2. Mailland F, Dal Bo L. In vitro antifungal activity and model of nail permeation of ciclopirox in a hidroxypropyl-chitosan nail lacquer. Proceedings of the 21st World Congress of Dermatology, 30 September-5 October 2007, Buenos Aires, Argentina.
3. Baran R, Mailland F. Transungual delivery of drugs: new perspectives (Abstract No. 435). Proceedings of the 34th Annual European Society for Dermatological Research (ESDR) Meeting, 9-11 September 2004, Vienna, Austria.
4. Legora M, Mailland F. Mechanism of adherence to the nail surface of a film formed by water soluble chitosan. Proceedings of the 16th Congress of the European Academy of Dermatology and Venereology, 16-20 May 2007, Vienna, Austria.
5. Mailland F, Dal Bo L, Frisenda L. Ciclopirox nail concentrations in vitro and after single and multiple applications on healthy fingernails of a hydroxypropyl-chitosan based nail lacquer. Proceedings of the 21st World Congress of Dermatology, 30 September-5 October 2007, Buenos Aires, Argentina.
6. Baran R, Sparavigna A, Setaro M, Mailland F. Computerized image analysis of nails affected by fungal infection: evaluation using digital photographs and manually defined areas. J Drugs Dermatol 2004 3 : 488 493.
7. Berger RS, Bowman JP. A reappraisal of the 21-day cumulative irritation test in man. J Toxicol Cut Ocular Toxicol 1982 1 : 109 115.
8. Center for Drug Evaluation and Research, US Food and Drug Administration. Guidance for Industry: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products. CDER, Rockville, MD, 1999.
9. European Agency for the Evaluation of Medicinal Products. Points to Consider on Switching Between Superiority and Non-inferiority, CPMP/EWP/482/99. EMEA, London, 1999.
10. Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol 2000 43 : 70 80.
11. Baran R, Hay R, Haneke E, Tosti A, Piraccini BM. Epidemiology. In Onychomycosis: The Current Approach to Diagnosis and Therapy. Martin Dunitz Pubs, London, 1999 : 6 9.
12. Terbinafine: Official FDA Information - Side Effects and Uses. [WWW document] http://www.drugs.com/pro/terbinafine.html (last accessed 5 December 2008).
13. Krob AH, Fleischer AB Jr., D'Agostino R Jr., Feldman SR. Terbinafine is more effective than itraconazole in treating toenail onychomycosis: results from a meta-analysis of randomized controlled trials. J Cutan Med Surg 2003 7 : 306 311. (Pubitemid 37410451)
14. Arca E, Taştan HB, Akar A, Kurumlu Z, Gür AR. An open, randomized, comparative study of oral fluconazole, itraconazole and terbinafine therapy in onychomycosis. J Dermatolog Treat 2002 13 : 3 9. (Pubitemid 34163692)
15. Fluconazole: Official FDA Information - Side Effects and Uses. [WWW document] http://www.drugs.com/pro/fluconazole.html (last accessed 5 December 2008).
16. Sporanox: Official FDA Information - Side Effects and Uses. [WWW document] http://www.drugs.com/pro/sporanox.html (last accessed 5 December 2008).
17. Reinel D, Clarke C. Comparative efficacy and safety of amorolfine nail lacquer 5% in onychomycosis, once weekly versus twice weekly. Clin Exp Dermatol 1992 17 : 44 49.
18. Scher RK, Tavakkol A, Sigurgeirsson B et al. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol 2007 56 : 939 944. (Pubitemid 46729696)