The Studies - Monotherapy
The two pivotal US trials were double blind placebo controlled trials involving 549 patients randomized 1:1, placebo:drug who applied ciclopirox daily for 48 weeks to their great toenails. The toenails had to have 20% to 65% ( mean 40%) of the plate involved without lunular involvement. These two studies showed a mycological cure (neg. culture and KOH) of 29% and 36% versus placebo of 11% and 9%.
A meta analysis of 10 studies performed world –wide involving 2027 patients with mild to moderate onychomycosis (20 to 65 % involvement without lunular involvement) showed a mean mycological cure (neg culture and KOH) of 52.6 % (range 46.7% to 85.7%).
[Gupta JAAD suppl October 2000 vol 43 #4]
The Studies - Combination Therapy
In my opinion, the combination of systemic therapy with Penlac is desirable in three clinical circumstances.
1. to reduce the amount of drug patients are exposed in situations that require systemic therapy (>75% involvement and lunula involvement)
A three arm study comparing 8 or 12 weeks of terbinafine with daily Penlac application versus 12 weeks of terbinafine monotherapy revealed mycological cure rates of 66.7% (8L) versus 70.4% (12L) versus 56%(12). 73 patients participated each with an average infection duration of 10 years, >60% nail involvement (mean84-89%) with lunular involvement. This study clearly demonstrates an effective combination with reduced drug exposure for the patient
2. to try and improve the response to systemic therapy in situations that are known to be difficult to treat (ie lateral nail disease, extensive onycholysis
3. to try to reduce the incidence of relapse\recurrence that occurs following systemic therapy alone
Ref: Gupta, et al. J Am Acad Dermatol 43(4 Pt 2):S70-S80 (2000 Oct)