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

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

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

Study Overview

• Status: Unknown
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Procedure: Methylene blue-mediated photodynamic therapy; Drug: Amorolfine 5% Nail Lacquer

Detailed Description

• 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 of PDT consisting of 6 treatment sessions with interval of 15 days between each session
  • Patient will be instructed that apply 40% urea cream under occlusive dressing for 5 days prior to PDT.

• Group B

  • Patients will be detailed instruction regarding the use of 5% Amorolfine Nail Lacquer as its recommended protocol.
  • Total duration of the follow-up is 18 months

Evaluation tool

• Nail photographs by using dermoscope for onychomycosis severity index (OSI) evaluation
• Either Scrape or nail clipping, which is positive prior to the treatment, will be performed for microscopic study and culture.
• Safety will be assessed through adverse events.
• Patients' satisfaction will be evaluated at the end of the treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Einapak Amnarttrakul, MD; Phone Number: 7521182743; Email: einapak.b@chula.ac.th
• Study Contact Backup: Name: Pravit Asawanonda, MD, PhD; Phone Number: 66818129393; Email: pravit.a@chula.ac.th, fibrosis@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
    • Contact: Nutthamon Bowornsathitchai, M.D.; Phone Number: 66818239488; Email: bee_o_bo@hotmail.com
    • Sub-Investigator: Anukorn Sriaram, B.Eng.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

  • Clinical signs of onychomycosis as following:

    • Discoloration
    • Dystrophy of nail plate
    • Subungual hyperkeratosis
    • Onycholysis

  • Confirmed by:

    • Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or
    • Positive microscopic evidence*
  • *any of these methods, direct microscopy (KOH preparation), nail plate culture on Sabouraud's dextrose agar (SDA), histopathological examination of nail clippings using PAS staining (HPE-PAS), histopathological examination of nail clippings using GMS staining (HPE-GMS), polymerase chain reaction

Exclusion Criteria:

• Those with nail changes because of skin disease or associated systemic diseases
• Pregnancy or lactating woman
• Those who are allergic to amorolfine, methylene blue
• Those who are photosensitive to visible light
• Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MB-PDT for Onychomycosis	Procedure: Methylene blue-mediated photodynamic therapy; Using the 2% MB aqueous solution as a photosensitiser. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm); Other Names: Incoherent red light (peak emission spectrum at 630-640 nm); Methylene blue
Active Comparator: Amorolfine for Onychomycosis	Drug: Amorolfine 5% Nail Lacquer; Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onychomycosis severity index (OSI)	Photographs taken by using a dermoscope were evaluated by two independent dermatologists.	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.

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Natthamon Bowornsathitchai, MD, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Onychomycosis; photodynamic therapy; methylene blue; amorolfine, nail lacquer; Asians
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Amorolfine; Methylene Blue
• Other Study ID Numbers: CU_MBPDT_for_Onychomycosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No