Indian Journal of Dermatology
ORIGINAL ARTICLE
Year
: 2019  |  Volume : 64  |  Issue : 4  |  Page : 253--260

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

Correspondence Address:
Amrita Sil
Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, Birbhum - 731 224, West Bengal
India

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.


How to cite this article:
Chandra S, Sancheti K, Podder I, Das A, Sarkar TK, Chowdhury M, Sil A, Bhattacharya S, Das NK. 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;64:253-260


How to cite this URL:
Chandra S, Sancheti K, Podder I, Das A, Sarkar TK, Chowdhury M, Sil A, Bhattacharya S, Das NK. 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 [serial online] 2019 [cited 2019 Sep 16 ];64:253-260
Available from: http://www.e-ijd.org/article.asp?issn=0019-5154;year=2019;volume=64;issue=4;spage=253;epage=260;aulast=Chandra;type=0