A Randomized, Double-blind Study of Amorolfine 5% Nail Lacquer with Oral Fluconazole Compared with Oral Fluconazole Alone in the Treatment of Fingernail Onychomycosis

Somodyuti Chandra; Karan Sancheti; Indrashis Podder; Anupam Das; Tushar Kanti Sarkar; Moitreyee Chowdhury; Amrita Sil; Susmita Bhattacharya; Nilay Kanti Das

doi:10.4103/ijd.IJD_385_17

A Randomized, Double-blind Study of Amorolfine 5% Nail Lacquer with Oral Fluconazole Compared with Oral Fluconazole Alone in the Treatment of Fingernail Onychomycosis

Indian J Dermatol. 2019 Jul-Aug;64(4):253-260. doi: 10.4103/ijd.IJD_385_17.

Authors

Somodyuti Chandra¹, Karan Sancheti¹, Indrashis Podder², Anupam Das³, Tushar Kanti Sarkar¹, Moitreyee Chowdhury⁴, Amrita Sil⁵, Susmita Bhattacharya⁶, Nilay Kanti Das⁷

Affiliations

¹ Department of Dermatology, Medical College, Rampurhat, Birbhum, West Bengal, India.
² Department of Dermatology, Sagore Datta Medical College, Rampurhat, Birbhum, West Bengal, India.
³ Department of Dermatology, KPC Medical College, Rampurhat, Birbhum, West Bengal, India.
⁴ Department of Biochemistry, Medical College, Rampurhat, Birbhum, West Bengal, India.
⁵ Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, Birbhum, India.
⁶ Department of Microbiology, Kalyani Medical College, Nadia, West Bengal, India.
⁷ Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.

Abstract

Background: It is a challenge to treat onychomycosis due to frequent treatment failures and relapses. Systemic and topical therapies need to be combined to improve cure rates. Antifungal susceptibility might play a role in the treatment resistance of onychomycosis.

Aims: To compare the safety and effectiveness of amorolfine 5% nail lacquer + oral fluconazole versus only oral fluconazole in the treatment of fingernail onychomycosis.

Methodology: In this double-blind trial (CTRI/2015/02/005369), patients were randomized (1:1) into amorolfine 5% nail lacquer + fluconazole and dummy lacquer + fluconazole. Treatment was given for 3 months with monthly follow-ups. Antifungal sensitivity was carried out for Candida. Effectiveness was assessed by reduction in the number and percentage area of nails involved and mycological cure. At the end of 3-month treatment period, the association between drug sensitivity and treatment response was explored for the Candida infections.

Results: Among 30 study participants, the combination group showed significantly lower number of nail involvement (P = 0.004) and percentage nail involvement (P = 0.005) than only fluconazole group. Pretreatment fungal culture showed a comparable number of dermatophytes, Candida, Aspergillus in both the groups. Sensitivity testing was done for the isolated Candida species. Antifungal sensitivity for Candida (n = 11) was tested, and 8 (72.7%) of the organisms were sensitive to fluconazole (minimum inhibitory concentration [MIC] 1.25 ± 1.19 μg/ml), 100% were sensitive to itraconazole (MIC 0.0726 ± 0.021 μg/ml), and 3 (27.3%) were susceptible-dose dependent (S-DD) to fluconazole (MIC 16 μg/ml). Fluconazole only group patients with Candida who showed resistance to fluconazole did not respond to therapy; however, patients in the combination group showed moderate improvement (reduction in area involvement = 55.56 ± 35.36%).

Conclusion: The combination of amorolfine/fluconazole achieved a higher cure rate not only for sensitive fungus but also for those which were S-DD to fluconazole.

Keywords: Amorolfine nail lacquer; fluconazole; onychomycosis; randomized control trial.