Efinaconazole effective against early onychomycosis.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY
Patients who have early onychomycosis can be effectively treated with once-daily efinaconazole topical solution, 10%, according to data from more than 1,000 subjects.
"Early treatment before the disease progresses to total dystrophic onychomycosis can increase cure rate and may avoid the need for systemic treatments," wrote study author Dr. Phoebe Rich, a dermatologist in group practice in Portland, Ore.
The study used two identical multicenter, randomized, double-blind, vehicle-controlled trials.
Of 1,655 subjects, 1,526 underwent randomization, and subjects were categorized according to disease duration at baseline.
A total of 74 subjects had onychomycosis for less than 1 year, 682 for 1-5 years, and 770 for more than 5 years. The primary endpoint was complete cure rate--defined as 0% clinical involvement of target toenail, and both negative results on a potassium hydroxide examination and a fungal culture--after 52 weeks (J. Drugs Dermatol. 2015;14:58-62).
After 52 weeks, 42.6% of patients with a baseline disease duration of less than 1 year had a complete cure with efinaconazole, compared with 16.7% on a vehicle (control).
In the 1- to 5-year group, 17.1% of patients with a baseline disease duration had a complete cure with efinaconazole, compared with 4.4% on vehicle (P < .001); in the group of subjects with a disease duration that was longer than 5 years, 16.2% of patients had a complete cure on efinaconazole, compared with 2.5% of patients on vehicle (P < .001).
In addition, 28.3% of patients with no other toenails affected at baseline had a complete cure with efinaconazole, compared with 23.7% on vehicle; 18.6% of patients with one to two nontarget toenails affected at baseline had a complete cure with efinaconazole, compared with 4.9% on vehicle (P < .001); and 16.5% of patients with more than two nontarget toenails affected at baseline had a complete cure on efinaconazole, compared with 0.1% on vehicle (P < .001).
"The availability of an effective topical treatment for onychomycosis could encourage earlier treatment and prevent the progression of the disease, where it would become more difficult to treat successfully," said Dr. Rich, who also cautioned that the study's 52-week length "may be too brief to evaluate a clinical cure in onychomycosis."
Key clinical point: Once-daily efinaconazole topical solution, 10%, can be effective in treating patients with early onychomycosis.
Major finding: After 52 weeks of treatment, 42.6% of patients with a baseline disease duration of less than 1 year had a complete cure with efinaconazole, compared with 16.7% on a control solution.
Data source: Two multicenter, randomized, double-blind vehicle-controlled studies including 1,655 adults aged 18-70 years.
Disclosures: Dr. Rich has served as a paid consultant to Valeant Pharmaceuticals and was a principal investigator in the pivotal trials with efinaconazole topical solution, 10%.
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|Publication:||Internal Medicine News|
|Article Type:||Clinical report|
|Date:||Feb 15, 2015|
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