Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
The aim of this prospective, investistigator-blinded, randomized and controlled clinical trial is to explore potential differences between 5 % amorolfine and 30 % resin lacquer in topical treatment of onychomycosis. In addition, topical treatment methods are compared with the most effective 'drug of choice' for onychomycosis according the current guidelines i.e. oral medication with terbinafine.
Altogether 90 patients (30 patients per group) who have culture or KOH stain verified onychomycosis are randomly allocated into three treatment groups to receive either topical treatment or oral medication for toe- or fingernail onychomycosis classified according to the current guidelines as follows:
- White superficial onychomycosis (WSO)
- Distal and lateral subungual onychomycosis (DLSO)
- Proximal subungual onychomycosis (PSO)
- [Total dystrophic onychomycosis) (TDO)] [Excluded]
- [Candidal onychomycosis] [Excluded]
Participants are randomized into three groups to receive:
- Topical treatment: 30 % resin lacquer (Abicin®)
- Topical treatment: 5 % amorolfine lacquer (Loceryl®)
- Oral medication: 250 mg terbinafine
All patients visit at outpatient department before the launch of the study, and three and nine months thereafter. Clinical examination is done by four physicians. At every visit, the panel of laboratory tests (S-Krea, S-GT, B-TVK), nail samples for mycological culturing and KOH staining (Sk-SienVi), and digital photographs are taken from the most severely affected onychomycotic nails. At the end of the study, all patients are ordered to discontinue using the resin- or amorolfine lacquer four weeks before the last visit (washout period). During the trial, all participants are contacted at least twice by phone in order to monitor the patient's compliance and willingness to continue in the trial.
In order to control safety and assess potential contraindications for terbinafine, amorolfine or resin, blood samples regarding kidney and liver function are taken in the beginning of the study, as well as at three and nine months, thereafter. The patients' permanent medication is verified against terbinafine, amorolfine and resin in order to exclude potential cross-reactions between the patient's permanent medication and current antifungal treatment. Sensitivity or allergy for terbinafine, amorolfine or resin is taken into account, and if any symptoms of allergic reactions appear, the study is discontinued for this particular patient.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Resin Lacquer vs. Amorolfine vs. Terbinafine in Treatment of Onychomycosis: Prospective, Investigator-blinded, Randomized and Controlled Clinical Trial|
- Mycological cure [ Time Frame: At 6- and 9 months time-points from the beginning of antifungal treatment ] [ Designated as safety issue: No ]To analyze the rate of mycological cure i.e. fungal eradication in terms of mycological culture and potassium hydroxide (KOH) stain during the treatment period.
- Clinical cure [ Time Frame: At 6- and 9 months time-points from the beginning of antifungal treatment ] [ Designated as safety issue: No ]To assess objective and subjective clinical treatment result according to the clinical classification of onychomycosis.
- Costs [ Time Frame: At 9 months time-point from the beginning of antifungal treatment ] [ Designated as safety issue: No ]To assess and compare the total costs of topical and oral treatment.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Amorolfine
Topical treatment with 5 % amorolfine lacquer (Loceryl)
Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for nine months in toenail onychomycosis and six months in fingernail onychomycosis.
Active Comparator: Terbinafine
Oral medication with 250 mg terbinafine / day
Terbinafine 250 mg is administered orally once a day for three months in toenail onychomycosis and six weeks in fingernail onychomycosis.
Active Comparator: Resin lacquer
Topical treatment: 30 % resin lacquer (Abicin)
Device: Resin lacquer
Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for nine months in toenail onychomycosis and six months in fingernail onychomycosis.
|Vääksy, Finland, FI-17200|
|Principal Investigator:||Janne J. Jokinen, MD, PhD||Dept. of Cardiothoracic Surgery, Helsinki University Hospital, Haartmaninkatu 4, PO Box 340, FI-00029 Helsinki, Finland|