A Randomised Study of the Efficacy, Safety and Cost Effectiveness of a Combination Therapy with Amorolfine Nail Lacquer and Oral Terbinafine Compared with Oral Terbinafine alone for the Treatment of Onychomycosis

Onychomycosis is the most common nail disease encountered by dermatologists. Dermatophytic nail infection accounts for 20% of all nail disorders. Onychomycosis can be difficult to treat, as relapses and re-infections are common. Onychomycosis may not be, in most cases, life threatening, but it is a life-impairing disease; several studies have documented the effects on patient quality of life.

The objective of our study is to compare the efficacy, safety and cost effectiveness of a combination therapy with topical amorolfine and oral terbinafine compared with oral terbinafine alone for the treatment of dermatophytic nail infection.

This is a single centre, randomised, comparative study, which was conducted in year 2012–2014. The study was done in 100 patients of onychomycosis. Dermatophytic nail infection was confirmed by clinical and mycological microscopic examination. Two groups of50 patientseach were made. Onegroup was given amorolfinenail lacquer topicallyalong with oral terbinafine once daily for 6 months and the second group was given oral terbinafine once daily alone for 6 months. The follow up of patients was done at 1, 3, 6 and 12 months and observations were noted and analysed.

It was observed that the results were significantly better in oral terbinafine and topical amorolfine combination group than oral terbinafine alone.

These results suggest that topical amorolfine nail lacquer along with oral terbinafine may be a better treatment modality with respect to efficacy, safety and cost-effectiveness in treatment of onychomycosis.