NCT03098342

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

February 20, 2017

Last Update Submit

May 9, 2026

Conditions

Onychomycosis of Toenail

Keywords

Onychomycosisphotodynamic therapymethylene blueamorolfine, nail lacquerAsians

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

MB-PDT for Onychomycosis

EXPERIMENTAL
Procedure: Methylene blue-mediated photodynamic therapy

Amorolfine for Onychomycosis

ACTIVE COMPARATOR
Drug: Amorolfine 5% Nail Lacquer

Interventions

Methylene blue-mediated photodynamic therapyPROCEDURE

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)

Also known as: Incoherent red light (peak emission spectrum at 630-640 nm), Methylene blue
MB-PDT for Onychomycosis
Amorolfine 5% Nail LacquerDRUG

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

Amorolfine for Onychomycosis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Bowornsathitchai N, Thammahong A, Shoosanglertwijit J, Kitsongsermthon J, Wititsuwannakul J, Asawanonda P, Boontaveeyuwat E. Methylene blue-mediated photodynamic therapy may be superior to 5% amorolfine nail lacquer for non-dermatophyte onychomycosis. Photodermatol Photoimmunol Photomed. 2021 May;37(3):183-191. doi: 10.1111/phpp.12624. Epub 2020 Nov 24.

    PMID: 33145834BACKGROUND

MeSH Terms

Conditions

Onychomycosis

Interventions

Methylene Blueamorolfine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Natthamon Bowornsathitchai, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 31, 2017

Study Start

June 1, 2017

Primary Completion

December 30, 2018

Study Completion

January 31, 2019

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)