Efficacy of topical resin lacquer, amorolfine and oral terbinafine for treating toenail onychomycosis: a prospective, randomized, controlled, investigator-blinded, parallel-group clinical trial
Summary Background Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans. Objectives To confirm previous in v...
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Published in | British journal of dermatology (1951) Vol. 173; no. 4; pp. 940 - 948 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Blackwell Publishing Ltd
01.10.2015
Oxford University Press |
Subjects | |
Online Access | Get full text |
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Summary: | Summary
Background
Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans.
Objectives
To confirm previous in vivo observations that a topical resin lacquer provides mycological and clinical efficacy, and to compare this lacquer with topical amorolfine hydrochloride lacquer and systemic terbinafine for treating dermatophyte toenail onychomycosis.
Methods
In this prospective, randomized, controlled, investigator‐blinded study, 73 patients with onychomycosis were randomized to receive topical 30% resin lacquer once daily for 9 months, topical 5% amorolfine lacquer once weekly for 9 months, or 250 mg oral terbinafine once daily for 3 months. The primary outcome measure was complete mycological cure at 10 months. Secondary outcomes were clinical efficacy, cost‐effectiveness and patient compliance.
Results
At 10 months, complete mycological cure rates with the resin, amorolfine and terbinafine treatments were 13% [95% confidence interval (CI) 0–28], 8% (95% CI 0–19) and 56% (95% CI 35–77), respectively (P ≤ 0·002). At 10 months, clinical responses were complete in four patients (16%) treated with terbinafine, and partial in seven (30%), seven (28%) and nine (36%) patients treated with resin, amorolfine and terbinafine, respectively (P < 0·05). Resin, amorolfine and terbinafine treatments cost €41·6, €56·3 and €52·1, respectively, per patient (P < 0·001).
Conclusions
Topical 30% resin lacquer and topical 5% amorolfine lacquer provided similar efficacy for treating dermatophyte toenail onychomycosis. However, orally administered terbinafine was significantly more effective in terms of mycological cure and clinical outcome than either topical therapy at the 10‐month follow‐up.
What's already known about this topic?
Treatment of dermatophyte onychomycosis is a clinical challenge.
Treatment failure is observed in 25–60% of patients with the current gold‐standard treatment, orally administered terbinafine.
When applied as a monotherapy, topical antifungals have shown limited results in treating dermatophyte onychomycosis, with < 30% overall mycological cure rates; however, more than half of patients with onychomycosis are treated with topical preparations.
What does this study add?
This is the first clinical trial to investigate the efficacy and safety of a 30% lacquer prepared from Norway spruce (Picea abies) in the treatment of dermatophyte onychomycosis.
This treatment was comparable with the most effective topical treatment currently on the market: synthetic amorolfine hydrochloride.
On the basis of mycological and clinical cures at 10‐month follow‐up, orally administered terbinafine was significantly more effective against onychomycosis than either topical therapy.
Linked Comment: Yong, Br J Dermatol 2015; 173: 888–889. |
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Bibliography: | istex:300810DBB6E522DD1736C960C67DD7F54120D078 ark:/67375/WNG-1FDWC7N6-L ArticleID:BJD13934 Repolar Ltd Linked Comment Yong, Br J Dermatol 2015; 173: 888–889 . ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 ObjectType-Article-1 ObjectType-Feature-2 |
ISSN: | 0007-0963 1365-2133 |
DOI: | 10.1111/bjd.13934 |