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

Chulalongkorn University

Status

Unknown

Conditions

Onychomycosis of Toenail

Treatments

Procedure: Methylene blue-mediated photodynamic therapy

Drug: Amorolfine 5% Nail Lacquer

Study type

Interventional

Funder types

Other

Identifiers

NCT03098342

CU_MBPDT_for_Onychomycosis

Details and patient eligibility

About

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

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.