Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study is conducted to corroborate the previous observational clinical trial with
      more valid methods and a more clinically relevant experimental design. This study aims to
      compare efficacy, safety, and cost between topically administered 30% resin lacquer for the
      treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5%
      amorolfine and systemic terbinafine.
    

Detailed description: 
      The aim of this prospective, investigator-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 (the aim is to collect the 30 patients per group) who have culture or
      potassium hydroxide (KOH) stain verified dermatophyte onychomycosis are randomly allocated
      into 3 treatment groups to receive either topical treatment or oral medication for toenail
      onychomycosis classified as follows:

        1. White superficial onychomycosis (WSO)

        2. Distal and lateral subungual onychomycosis (DLSO)

        3. Proximal subungual onychomycosis (PSO)

        4. [Total dystrophic onychomycosis) (TDO)] [Excluded]

        5. [Candidal onychomycosis] [Excluded]

      Participants are randomized into 3 groups to receive:

        1. Topical treatment: 30 % resin lacquer (Abicin®) applied once daily for 9 months.

        2. Topical treatment: 5 % amorolfine lacquer (Loceryl®) applied once weekly for 9 months.

        3. Oral medication: 250 mg terbinafine taken orally once daily for 3 months.

      All patients visit at outpatient department before the launch of the study, and 3 and 9
      months thereafter. Clinical examination is done by 4 physicians. During the 42-week study
      period, laboratory tests are conducted on samples collected before treatment, at 20 weeks,
      and at 42 weeks. The tests include a fungal culture, KOH staining of the toenail sample, and
      blood tests. Cultures and KOH microscopy are performed in an independent, specialised
      mycology laboratory with standard techniques (Medix Laboratories Ltd., Helsinki, Finland).
      The blood tests measure plasma γ-glutamyl transferase levels (also at 2 weeks); plasma
      creatinine levels; the total number of white blood cells, including neutrophils, monocytes,
      basophils, lymphocytes, and eosinophils; the total number of red blood cells, including
      erythrocytes and haematocrit; erythrocyte indices, including the mean corpuscular volume,
      mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, and haemoglobin
      level; and the total number thrombocytes (initially and at 42 weeks). During the control
      visits, sequential digital photographs of the most disfigured and brittle toenails are
      acquired.

      In the three phone calls, patients are asked about potential treatment-related side effects,
      compliance with treatment, patients' perception of treatment outcome, and their willingness
      to continue in the study. In each treatment arm, the treatment regimen is discontinued 5
      weeks before the last toenail sampling to provide an appropriate washout period before the
      final culture and KOH analysis.

      To ensure safety and to assess potential contraindications for the treatment regimens, all
      patients included in the study undergo a comprehensive medical interview and physical
      examination. To identify patients who may develop intolerable adverse events due to drug
      combinations, all concurrent medications are cross-checked to verify compatibility with
      resin, amorolfine, and terbinafine regimens at the beginning of the study. All patients are
      informed of the possibility of developing a hypersensitivity to resin, amorolfine, or
      terbinafine. If patients experienced symptoms that corresponded to any level of
      hypersensitivity, they are dropped from the study.
    

Intervention name(s): Resin Lacquer; Amorolfine; Terbinafine
Intervention type(s): Device; Drug; Drug
Intervention description(s): 30% Resin Lacquer is applied once daily for 9 months (Abicin®) in toenail onychomycosis.; 5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.; 250 mg of Terbinafine is taken orally once daily for 3 months (Generics) in toenail onychomycosis.
Other intervention name(s): Resin Lacquer arm; Amorolfine Lacquer arm; Terbinafine arm
Intervention MeSH terms: Terbinafine; Amorolfine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dermatophyte onychomycosis; Fungal nail infection; Resin Lacquer; Amorolfine; Terbinafine