Clinical Trial: Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians

Brief Summary:

Study centre and address

King Chulalongkorn Memorial Hospital

Primary objective

To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5% amorolfine nail lacquer for toenail onychomycosis in Asians

Detailed Summary:

• Research Design

Randomized, single-blind clinical trial

• Research Methodology

Target population

• 42 Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically

• Patients were recruited from Dermatology clinic, King Chulalongkorn Memorial Hospital

  • Exclusion criteria

    1. Those with nail changes because of skin disease or associated systemic diseases
    2. Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.

  • Methods

    1. Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
    2. They will be included in stratified randomly by poor prognostic factors, then divided into two groups (A: methylene blue-mediated photodynamic therapy (MB-PDT) and B: 5% Amorolfine Nail Lacquer by block randomization of size 4 and 6.
    3. For 24 weeks,

• Group A

  • The use
    Sponsor: Chulalongkorn University
    

    Current Primary Outcome: Onychomycosis severity index (OSI) [ Time Frame: Change from baseline Onychomycosis severity index at every 2 weeks through the MB-PDT treatment completion, 12 weeks; then change from baseline Onychomycosis severity index at every 8 weeks through the study completion, an average of 18 months. ]

    Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
    
    
    

    Original Primary Outcome: Same as current
    
    

    Current Secondary Outcome:
    
    

    Original Secondary Outcome:
    
    Information By: Chulalongkorn University
    

    Dates:
    Date Received: February 20, 2017
    Date Started: June 1, 2017
    Date Completion: January 31, 2019
    Last Updated: March 27, 2017
    Last Verified: February 2017