title: Efficacy of topical resin lacquer, amorolfine and oral terbinafine for treating toenail onychomycosis: a prospective, randomized, controlled, investigator-blinded, parallel-group clinical trial.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Vascular Surgery, Heart Centre, Kuopio University Hospital, FI-70029, Kuopio, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Auvinen
authors.affiliation: Department of Orthopaedics and Traumatology, Päijät-Häme Central Hospital, FI-15850, Lahti, Finland.
authors.forename: R
authors.initials: R
authors.lastname: Tiihonen
authors.affiliation: Department of Orthopaedics and Traumatology, Päijät-Häme Central Hospital, FI-15850, Lahti, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Soini
authors.affiliation: Vääksy Medical Centre, FI-17200, Vääksy, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Wangel
authors.affiliation: Department of Orthopaedics and Traumatology, Päijät-Häme Central Hospital, FI-15850, Lahti, Finland.
authors.forename: A
authors.initials: A
authors.lastname: Sipponen
authors.affiliation: Department of Cardiac Surgery, Heart and Lung Centre, Helsinki University Hospital, FI-00029, Helsinki, Finland.
authors.forename: J J
authors.initials: JJ
authors.lastname: Jokinen
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D007764:Lacquer; D008297:Male; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D014009:Onychomycosis / Q000188:drug therapy*; D011446:Prospective Studies; D012116:Resins, Plant / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D000077291:Terbinafine; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D009025:Morpholines; D009281:Naphthalenes; D012116:Resins, Plant; C038974:amorolfine; D000077291:Terbinafine