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Indian J Dermatol Venereol Leprol. 2018 Nov 5. doi: 10.4103/ijdvl.IJDVL_907_17. [Epub ahead of print]

A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis.

Author information

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.

Abstract

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.

KEYWORDS:

Amorolfine; randomized controlled trial sertaconazole; tinea corporis; tinea cruris

PMID:
30409926
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