Topical amorolfine for 15 months combined with 12 weeks of oral terbinafine, a cost-effective treatment for onychomycosis.
OBJECTIVE
This open randomized study examined the efficacy of a combination of oral terbinafine and topical amorolfine in the treatment of severe dermatophyte toenail onychomycosis with matrix area involvement.


METHODS
A total of 147 patients were randomized to one of three treatment groups: 15 months of once-weekly topical amorolfine lacquer in combination with 6 weeks (Group AT6) or 12 weeks (Group AT12) of oral terbinafine, 250 mg once daily: or terbinafine monotherapy for 12 weeks (Group T12). Patients were followed for a total of 18 months. The primary efficacy variable was the result of mycological examination after 3 months of therapy; secondary efficacy variables were mycological and clinical examination at 3-monthly intervals, with an additional clinical evaluation at 18 months. Safety and tolerance were also assessed.


RESULTS
Negative mycological results, assessed at 3 months, were recorded for 14 of 40 patients (35%) in Group AT6, 11 of 44 (27.5%) in Group AT12 and 7 of 41 (17.1%) in Group T12. At 18 months, the global response (mycological and clinical cure) was seen in 22 of 50 patients (44%), 34 of 47 (72.3% and 18 of 48 (37.5%) in the AT6, AT12 and T12 groups, respectively.


CONCLUSIONS
These results suggest that a combination therapy regime with oral and systemic treatment is superior in efficacy to monotherapy with a systemic drug alone in the treatment of severe onychomycosis. In addition, the cost per cure ratio was better in the combination groups.
Baran
R
R
Nail Disease Center, Le Grand Palais, Cannes, France. baran.r@club-internet.fr
D000284:Administration, Oral; D000287:Administration, Topical; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005533:Foot Dermatoses / Q000188:drug therapy; D006801:Humans; D009025:Morpholines / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D009281:Naphthalenes / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy*; D000077291:Terbinafine
D000935:Antifungal Agents; D009025:Morpholines; D009281:Naphthalenes; C038974:amorolfine; D000077291:Terbinafine