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

Onychomycosis of Toenail Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03098342
• Other study ID #: CU_MBPDT_for_Onychomycosis
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: March 27, 2017
• Start date: June 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2017
• Source: Chulalongkorn University
• Contact: Einapak Amnarttrakul, MD
• Phone: 7521182743
• Email: einapak.b[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenail

Intervention

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)

Drug:
• Amorolfine 5% Nail Lacquer
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.