A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis
Anirban Das1, Amrita Sil2, Tushar Kanti Sarkar3, Arpita Sen3, Sriparna Chakravorty4, Manideepa Sengupta4, Anupam Das3, Somodyuti Chandra3, Santasmita Pal5, Debabrata Bandyopadhyay3, Nilay Kanti Das6
1 Department of Dermatology, Murshidabad Medical College and Hospital, Berhampore, West Bengal, India
2 Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, India
3 Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India
4 Department of Microbiology, Medical College and Hospital, Kolkata, West Bengal, India
5 Department of Biochemistry, Medical College and Hospital, Kolkata, West Bengal, India
6 Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India
Flat 3I, Block 4, 83A Cossipore Road, Kolkata - 700 002, West Bengal
Source of Support: None, Conflict of Interest: None
Background: Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients.
Aims: To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis.
Methods: A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters.
Results: Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010).
Limitations: Antifungal susceptibility testing could not be done.
Conclusion: Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards.