There is no good evidence from randomized controlled trials (RCTs) on the effectiveness of topical amorolfine for dermatophyte onychomycosis.

Because different studies measure cure outcomes differently, and assess cure rates at different times, it is not straightforward to compare cure rates from different observational studies.

Systematic reviews (most recent search: June 2006) found no RCTs that compared topical amorolfine with placebo or other topical treatments for dermatophyte onychomycosis [Crawford and Ferrari, 2007; Crawford and Hollis, 2007].

Topical amorolfine compared with placebo

• CKS found no RCTs.

Topical amorolfine once a week compared with topical amorolfine twice a week

• An RCT (n = 456) found that topical amorolfine applied twice a week was slightly more effective than applying it once a week, but the difference was not statistically significant [Reinel, 1992].
• Amorolfine 5% nail lacquer was applied to affected nails of the fingers or toes once or twice weekly for up to 6 months.
• Three months after completion of treatment, cure rates were not significantly different.
• Complete cure rates in the once-a-week and twice-a-week groups were: 46% compared with 54% (p = 0.4).
• Mycological cure rates in the once-a-week and twice-a-week groups were: 71% compared with 76% (statistical significance not reported).

Topical amorolfine in different vehicles

• An unblinded RCT (n = 34) found no difference between topical amorolfine 5% plus methylene and topical amorolfine 5% plus ethanol [Mensing et al, 1992].
• At 3 and 14 days after completion of treatment the relative risk of cure was 1.00 (95% CI 0.85 to 1.18).
• The study was statistically underpowered.

Topical amorolfine added to oral antifungal treatment

• See:
• Oral itraconazole compared with oral itraconazole plus a topical antifungal.
• Oral terbinafine compared with oral terbinafine plus a topical antifungal.