Onychomycosis of ToenailNCT03098342
Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
A study testing Methylene blue-mediated photodynamic therapy and Amorolfine 5% Nail Lacquer in people with Onychomycosis of Toenail, run by Chulalongkorn University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Methylene blue-mediated photodynamic therapy and Amorolfine 5% Nail Lacquer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Those with nail changes because of skin disease or associated systemic diseases
- Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
- Methods
- Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
- 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.
- 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.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Methylene blue-mediated photodynamic therapy, Amorolfine 5% Nail Lacquer
- Keywords
- Onychomycosis, photodynamic therapy, methylene blue, amorolfine, nail lacquer, Asians
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue-mediated photodynamic therapyProcedure or surgery
Also called Incoherent red light (peak emission spectrum at 630-640 nm), Methylene blue
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)
Amorolfine 5% Nail LacquerDrug
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
| Study group | Role | What they receive |
|---|---|---|
| MB-PDT for Onychomycosis | Experimental | Not described Receives: Procedure: Methylene blue-mediated photodynamic therapy |
| Amorolfine for Onychomycosis | Active comparator | Not described Receives: Drug: Amorolfine 5% Nail Lacquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onychomycosis severity index (OSI)
Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jun 2017
- Primary completion30 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Principal investigator, Einapak Boontaveeyuwat, MD, Chulalongkorn University
- Investigators
- Natthamon Bowornsathitchai, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098342
- Sponsor's protocol ID
- CU_MBPDT_for_Onychomycosis
- Status last verified
- May 2026
- First submitted
- 20 Feb 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33145834
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians
- ClinicalTrials.gov ID
- NCT03098342
- Acronym / sponsor ID
- CU_MBPDT_for_Onychomycosis
- Conditions
- Onychomycosis of Toenail
- Keywords
- Onychomycosis, photodynamic therapy, methylene blue, amorolfine, nail lacquer, Asians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Those with nail changes because of skin disease or associated systemic diseases
- Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
- Methods
- Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-PDT for Onychomycosis | Experimental | Procedure: Methylene blue-mediated photodynamic therapy |
| Amorolfine for Onychomycosis | Active comparator | Drug: Amorolfine 5% Nail Lacquer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blue-mediated photodynamic therapyAlso: Incoherent red light (peak emission spectrum at 630-640 nm), Methylene blueUsing 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) | Procedure or surgery | MB-PDT for Onychomycosis |
| Amorolfine 5% Nail LacquerPatients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol. | Drug | Amorolfine for Onychomycosis |
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 33145834Bowornsathitchai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natthamon Bowornsathitchai, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue-mediated photodynamic therapy and Amorolfine 5% Nail Lacquer in people with Onychomycosis of Toenail, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.