Butenafine, a fungicidal benzylamine derivative, used once daily for the treatment of interdigital tinea pedis

Abstract

A multi‐center, randomized, double‐blind, placebo‐controlled trial was performed to evaluate the effectiveness of butenafine, a fungicidal benzylamine derivative, in the once daily treatment of interdigital tinea pedis. One hundred and fifty patients with interdigital tinea pedis characterized by a minimum erythema score of 2 and a minimum score of 2 for either pruritus or scaling (on a scale of 0–3, where ‘2’ defines moderate severity) were initially enrolled, pending confirmation by mycologic culture and KOH testing. Patients were excluded if the evaluation of tinea pedis might have been impaired by concomitant conditions, if they were hypersensitive to allylamines or ingredients of the study medications, or if they had clinically significant abnormal laboratory values. Women of childbearing potential were also excluded if they were pregnant, lactating, or not using adequate contraceptive measures. The patients were randomized and given study formulations in coded tubes containing either butenafine hydrochloride cream 1% (butenafine) or the vehicle. They were instructed to apply the formulation to all tinea pedis lesions one daily, for 4 weeks. They were evaluated after 1, 2, and 4 weeks of treatment, and again 4 weeks post‐treatment, using the following measures: (i) mycologic cure: negative fungal culture and KOH test; (ii) effective treatment: mycologic cure and investigator global assessment of 80% or more improvement in signs and symptoms; (iii) investigator global assessment of clinical response: cleared (100% improvement in signs and symptoms), excellent (80–99% improvement), good (50–79% improvement), fair (25–49% improvement), poor (less than 25% improvement), unchanged, or worse, (iv) patient’s assessment of change since baseline: 5=greatly improved, 4=somewhat improved, 3=the same, 2=somewhat worse, and 1=much worse. Mycologic cure and effective treatment were each analyzed using the Cochran–Mantel–Haenszel (CMH) test of response by treatment partialled on investigator. Patient perceptions and investigator evaluations of global response were analyzed as ordered categorical data using the CMH mean score test with uniform scores.

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis

“…Scoring Clinical Index for Onychomycosis (SCIO) 18 Score Grade Description 0 None • No infection 1 Mild • Depth of involvement <1/3 • Scaling/ hyperkeratosis absent or <1 mm • Discolouration of nail 2 Moderate • Depth of involvement 1/3 to 2/3 • Scaling/ hyperkeratosis 1–2 mm • Acute Paronychia [acute inflammation surrounding nail(s)] • Nail plate dystrophy up to 50%. 3 Severe • Depth of involvement >2/3 • Scaling/ hyperkeratosis >2 mm • Chronic Paronychia [chronic inflammation surrounding nail(s)] • Nail plate dystrophy >50% C. Investigator Global Assessment (IGA) response 20 Score Response Description 5 Cleared 100% remission except residual manifestations 4 Excellent 90–99% improvement 3 Good 50–89% improvement 2 Fair 25–49% improvement 1 Poor <24% improvement 0 Worse deterioration from baseline Tinea lesions scoring [ 19 ] (A). Onychomycosis scoring - Scoring Clinical Index for Onychomycosis (SCIO) [ 18 ] (B).…”

“… Tinea lesions scoring [ 19 ] (A). Onychomycosis scoring - Scoring Clinical Index for Onychomycosis (SCIO) [ 18 ] (B).…”

“…Assessment of Onychomycosis severity scores was based on clinical practice opinions and the Scoring Clinical Index for Onychomycosis (SCIO) [ 18 ]. Scoring of the severity of Tinea lesions were based on clinical experience and adapted from Reyes et al [ 19 ]. Safety evaluation included assessment of adverse events and assessment of vital signs.…”

Interdigital tinea pedis (dermatophytosis simplex and complex) and treatment with ciclopirox 0.77% gel

“…Agents that have been evaluated for the treatment of moderate to severe tinea pedis (according to the above scale) include topical formulations of butenafine 14–16 , terbinafine 17–19 , clotrimazole 17 , oxiconazole 19,20 , naftifine 19 and miconazole nitrate 21 (Table 1). In these studies, the tinea pedis interdigitalis may have been of the dermatophytosis simplex variety, although it is difficult to be sure whether it was the dermatophytosis complex variety that was being treated.…”

Comparison of Superficial Mycosis treatment using Butenafine and Bifonazole nitrate Clinical Efficacy

“…Superficial mycosis has been considered to be as major world public health problem and one of the most frequent diseases in human beings and animals ( Burns et al, 2004 ; Kibbler et al, 1996 ; Midgley et al, 1997 ; Merlin et al, 1990) . Hence; the superficial mycosis clinical treatment has been introduced by many of antifungal agents ( Zarowny et al, 1995 ; Fredriksson, 1983 ; Kokoschka et al, 1986 ; McVie et al, 1986 ; Groll & Tragiannidis, 2010 ; Nolting et al, 1992 ; Reyes et al, 1998 ; Del Palacio et al, 1999) . Nevertheless the increased use of such agents in recent years has caused the development of resistance to available drugs.…”