BERLIN — A formulation of 8% ciclopirox-medicated nail lacquer for onychomycosis significantly outperformed a commercially available version in a 467-patient, 60-week randomized trial.
The product, 8% ciclopirox hydroxypropyl-chitosan nail lacquer (CicloPoli, Polichem), or P-3051, had an overall 119% greater mycologic cure rate than the commercially available 8% ciclopirox monoester (Penlac, Sanofi-Aventis).
Penlac significantly outperformed placebo, as expected based on earlier product registration studies in Europe, Dr. Federico Mailland reported at the annual congress of the European Academy of Dermatology and Venereology.
CicloPoli is currently only available in Europe. Penlac is available in Europe andithe United States.
The multicenter trial involved patients with toenail onychomycosis of varying severity who were randomized 2:2:1 to P-3051, Penlac, or placebo. They treated themselves for 48 weeks and were followed for another 12 weeks (J. Eur. Acad. Dermatol. Venereol. 2009;23:773-81).
The results varied markedly depending upon baseline severity. Mild disease was defined as baseline involvement of less than 25% of the big toenail, and severe as greater than 65% involvement.
The 60-week cure rate, defined as negative mycology by both KOH (potassium hydroxide) and culture, along with a 100% healthy-appearing nail, was 50% in patients with P-3051-treated mild disease and 0% with Penlac. For patients with moderate disease, the 60-week cure rates were 12.3% with P-3051 and 7.1% for Penlac. And for severe disease, the cure rates were 5.7% and 3.6%, respectively, said Dr. Mailland of Polichem SA in Lugano, Switzerland (manufacturer of CicloPoli).
The same pattern was seen with responder rates as defined by negative mycology and at least a 90% healthy-appearing nail. For patients with baseline mild fungal disease, the 60-week responder rates were 62.5% with P-3051 and 40% with Penlac. For moderate disease, responder rates were 31.6% and 17.7%. For severe disease, response rates were 11.4% with P-3051 and 3.6% with Penlac.
The new topical nail lacquer is an attractive alternative to oral treatment, even in severely affected patients, provided they are prepared for long-term therapy, said Dr. Mailland.