By Jenny Powers
BERLIN -- October 15, 2009 -- A new nail lacquer composed of 8% ciclopirox hydroxypropyl-chitosan (P-3051), showed to be more effective for the treatment of onychomycosis, at all disease stages, than oral treatment with 8% ciclopirox monoester, researchers reported here at the 18th Congress of the European Academy of Dermatology and Venereology (EADV).
The decision to treat patients with onychomycosis nail fungus is generally made based upon the clinical type and the disease severity, as determined by the number of infected nails and the degree of nail involvement.
Federico Mailland, MD, Scientific Department of the Polichem SA, Lugano, Switzerland, noted on October 9 that no clinical trials have compared the efficacy of topical versus systemic treatments according to disease severity.
The study included 467 patients with dermatophyte distal subungual onychomycosis. Patients were stratified by the extent of target involvement; big toenail involvement was mild at <25%; moderate was >=25% to 65%; and severe was >65%.
Patients were randomised to treatment with either 8% ciclopirox hydroxypropyl-chitosan nail lacquer (n = 157), placebo vehicle (n = 76), or 8% ciclopirox monoester market reference (n = 158) for 48 weeks. Patients were followed up for 12 weeks.
Researchers defined a "cure" as a patient having negative mycology and 100% healthy nail and defined a "responder" as a patients with negative mycology and >=90% healthy nail at week 60.
Responder response rates with all treatments at week 60 were 50.0% in mild, 22.4% in moderate, and 6.5% in severe patients. Cure rates were 16.7%, 7.8%, and 3.9% across the same categories. Negative cultures were determined in 80.0%, 78.8%, and 74.4% of patients receiving the nail lacquer, oral reference, and placebo, respectively.
Cure was achieved in 50.0%, 12.3%, and 5.7% of patients receiving the nail lacquer in mild, moderate, and severe stages, respectively, compared with 0.0%, 7.1%, and 3.6% across the same categories of patients receiving reference drug. Responders were 62.5%, 31.6%, and 11.4% in the nail lacquer group and 40.0%, 17.7%, and 3.6% in the reference treatment group for mild, moderate, and severe categories, respectively.
The efficacy of all treatments was dependent on the extent of nail involvement at baseline, however long lasting effects at all disease levels may be achieved with topical, as opposed to systemic treatment, the authors concluded.
[Presentation title: Influence of Illness Severity on the Efficacy of Topical Onychomycosis Treatment. Abstract 830]
E-Mail this DGDispatch to a colleague
