A phase III randomized controlled clinical trial evaluating the efficacy and safety of naftifine 2% cream versus terbinafine 1% cream in patients with superficial fungal infection of the skin

Authors

  • Nibedita Patro Department of Skin and VD, Hi-Tech Medical College and Hospital, Pandara, Bhubaneswar, Odisha, India
  • Prerna R. Suryatale Department of Dermatology, Jeevan Rekha Hospital, Belagavi, Karnataka, India
  • Ipsa Pandya Department of Dermatology, Aatman Hospital, Bopal, Ahmedabad, Gujarat, India
  • Nadia Zakir Mian Department of Dermatology, Prakhar Hospital Pvt. Ltd, Kanpur, Uttar Pradesh, India
  • Monika Chinda Department of Medical Affairs, Zydus Healthcare Ltd., Mumbai, Maharashtra, India
  • Pavankumar M. Daultani Department of New Product Development, Zydus Healthcare Limited, Ahmedabad, Gujarat, India
  • Ravindra Mittal Department of New Product Development, Zydus Healthcare Limited, Ahmedabad, Gujarat, India
  • Ashok D. Jaiswal Department of Medical Affairs, Zydus Healthcare Ltd., Mumbai, Maharashtra, India
  • Anit Singh Clinical Research Network India, Delhi, India

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20241599

Keywords:

Dermatophytosis, Naftifine, Terbinafine, Superficial skin fungal infection, Topical antifungals

Abstract

Background: Dermatophytosis is the prevailing fungal infection, typically addressed through topical, systemic antifungal medications, or a combination of both. Naftifine hydrochloride, belonging to the allylamine group, is a topical antifungal, exhibiting fungicidal properties alongside antibacterial and anti-inflammatory effects. This study evaluated the efficacy and safety of naftifine hydrochloride 2% w/w in 268 patients with dermatophytosis versus terbinafine hydrochloride 1% w/w.

Methods: The drugs were applied daily for two weeks, with the primary endpoint being a clinical cure at the end of the treatment. Secondary endpoints included mycological cure, composite cure, global efficacy assessment, and post-treatment relapse.

Results: In both groups, most patients experienced both clinical and mycological cures, with composite cures observed in 94.07% of the test group and 87.97% of the reference group. The global assessment of efficacy was 3.59 in the test group and 3.48 in the reference group, showing no notable difference between the two groups. All adverse events in both groups were mild and resolved within four days. Overall tolerability was comparable between the study groups.

Conclusions: The study concluded that topical naftifine was effective and safe in patients with dermatophytosis and its efficacy and safety were found comparable to topical terbinafine.

 

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Published

2024-06-05

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Original Research Articles