Non-dermatophyte OnychomycosisPhase 4NCT02812043
Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis
A Phase 4 study testing 1,064nm Long-pulsed Nd:YAG and Amorolfine in people with Non-dermatophyte Onychomycosis, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-dermatophyte Onychomycosis
- What is being tested?
- 1,064nm Long-pulsed Nd:YAG and Amorolfine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2016to Dec 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients aged more than 18 years old.
- The patients were diagnosed with non-dermatophytes or mixed-infection onychomycosis from both KOH examination and fungal cultured.
- The patients did not have any prior anti-fungal treatment within 6 months
- The patients did not receive any vasodilator drugs or isotretinoin within 6 months
- The patients who are willing to participate, and accept the methods and risk
Who cannot join
- The patients who suffered other medical dermatologic condition associated with onychomycosis such as psoriasis, paronychia etc.
- The patients who took immunosuppressive drugs, or the immunocompromised host.
- The patients who had severe vascular disease, such as severe DVT, or poor capillary refill time.
- The patients who had onychomycosis which involved in nail matrix.
- Pregnancy or lactation.
- The patients who had problems communication or have difficulty travel to the faculty for the checkup.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: Comparison of the Efficacy and Safety Between Long-pulsed Nd:YAG, Amorolfine and Combination of Long-pulsed Nd:YAG and Amorolfine in Treating Non-dermatophyte and Mixed-infection Onychomycosis
This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis.
Read the detailed description
Onychomycosis is the most common cause of nail deformities resulting with more than 50% of the patients with abnormal nails. From the institution of dermatology of Thailand, it confirmed that 1.7% of Thai population have onychomycosis. Most of the patients aged between 40-60 years old with female predominated. The common cause of onychomycosis worldwide is dermatophyte group, found in more than 50% of the patients. However, in Thailand, the study showed that 51.6% of patients with onychomycosis were infected by non-dermatophyte group especially Neoscytalidium spp.
The goal standard treatment for onychomycosis was oral anti-fungal drugs such as Fluconazole, Itraconazole and Terbinafine. But many patients were limited to the oral medications due to drug interaction between other CYP P2C9 inhibition such as statins, causing the risk of rhabdomyolysis and hepatotoxicity. Even though these medications are effective against dermatophytes. The non-dermatophytes which were the leading pathogens for onychomycosis in Thailand tends to be resistant to the oral medications. Therefore topical and other modalities have become an important role for treating those non-dermatophytes onychomycosis such as topical anti-fungals, topical urea cream and laser treatment. So far, no standard treatment has been made in order to treat the non-dermatophyte onychomycosis causing problems to both patients and physicians in Thailand.
Amorolfine is a morpholine derivative used in topical anti-fungal that inhibits the biosynthesis of the fungal cell membrane and showed fungicidal activities. From the previous study, amorolfine is an effective topical treatment against non-dermatophyte onychomycosis with 52-55% mycological cure rate and the clinical cure rate varied from 12.7%-54% depending on the studies. The side effects were minimal and the application was simple to use. So amorolfine is used as a first line treatment for non-dermatophyte onychomycosis in our practice. However, with the long treatment (from 6 months up to 1 year) and the low mycological cure rate newer modality had been studied to deal with this problematic pathogens.
Long-pulsed Nd:YAG laser had been used to treat onychomycosis with a promising result. In 2013, Kostas Kalokasidis used long-pulsed Nd:YAG for the onychomycosis and showed a 94.5% mycological cure rate with no relapse of the disease within 3 months. Later on, Rungsima Wanitphakdeedecha M.D. tried the long-pulsed Nd:YAG to treat onychomycosis and found the significant result that long-pulsed Nd:YAG can cure up to 95.42% onychomycosis from non-dermatophyte group. But the protocol was performed the laser treatment every 2 weeks for 1 month which made it difficult for the patient to come to the hospital, moreover the duration to treat onychomycosis might needed to be longer.
So the investigators came up with this study to compare the efficacy of long-pulsed Nd:YAG with 4-week intervals to the amorolfine and the combination of both Nd:YAG and amorolfine to see the mycological result and also the clinical improvement.
The treatment and KOH examination and fungal culture will be performed every month for 4 months, and then the follow up will be at 6 months after the first treatment
- Conditions
- Non-dermatophyte Onychomycosis
- Being tested
- 1,064nm Long-pulsed Nd:YAG, Amorolfine
- Keywords
- onychomycosis, amorolfine, long-pulsed Nd:YAG, fungal infection
- Medical subject headings
- Onychomycosis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,064nm Long-pulsed Nd:YAGDevice
Also called Dualis SP; Fotona, Lujbljana
Long-pulsed 1,064nm will be used for the treatment of onychomycosis which wll use 35-45 J/cm2 spot size 4, frequency 1 Hz for 2 passes on the infected nails
AmorolfineDrug
Amorolfine nail lacquer will be applied by the patient once a week on the infected nails
| Study group | Role | What they receive |
|---|---|---|
| Amorolfine | Experimental | This group of patients will receive only amorolfine nail lacquer to apply on the affected nail and the KOH examination and fungal culture will be performed every month Receives: Drug: Amorolfine |
| Long-pulsed Nd:YAG | Experimental | This group of patients will receive only the long-pulsed Nd:YAG (Cynergy®, 5 Carlisle Road Westford, MA USA) fluence 35-45 J/Cm2, spot size 4mm for 2 passes each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month Receives: Device: 1,064nm Long-pulsed Nd:YAG |
| Amorolfine+Long-pulsed Nd:YAG | Experimental | This group of patients will receive both amorolfine nail lacquer and the long-pulsed Nd:YAG laser treatment each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month Receives: Device: 1,064nm Long-pulsed Nd:YAG; Drug: Amorolfine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Mycological cure defined as negative Mycological culture
Measured: 6 months after treatment
Secondary outcomes (15)
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Mycological cure rate
Measured: 1 month after treatment
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Mycological cure rate
Measured: 2 months after treatment
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Mycological cure rate
Measured: 3 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
number of participants
Measured: 1 month after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
number of participants
Measured: 2 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
number of participants
Measured: 3 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
number of participants
Measured: 6 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
pain score
Measured: 1 month after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
pain score
Measured: 2 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
pain score
Measured: 3 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
pain score
Measured: 4 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Depth of nail
Measured: 1 month after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Depth of nail
Measured: 2 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Depth of nail
Measured: 3 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Depth of nail
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-dermatophyte OnychomycosisStudies of the same condition, open and under way.
- More trials run by Mahidol 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812043
- Sponsor's protocol ID
- 391/2558(EC1)
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety Between Long-pulsed Nd:YAG, Amorolfine and Combination of Long-pulsed Nd:YAG and Amorolfine in Treating Non-dermatophyte and Mixed-infection Onychomycosis
- ClinicalTrials.gov ID
- NCT02812043
- Acronym / sponsor ID
- 391/2558(EC1)
- Conditions
- Non-dermatophyte Onychomycosis
- Keywords
- onychomycosis, amorolfine, long-pulsed Nd:YAG, fungal infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- 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.
This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis.
Detailed description
Onychomycosis is the most common cause of nail deformities resulting with more than 50% of the patients with abnormal nails. From the institution of dermatology of Thailand, it confirmed that 1.7% of Thai population have onychomycosis. Most of the patients aged between 40-60 years old with female predominated. The common cause of onychomycosis worldwide is dermatophyte group, found in more than 50% of the patients. However, in Thailand, the study showed that 51.6% of patients with onychomycosis were infected by non-dermatophyte group especially Neoscytalidium spp.
The goal standard treatment for onychomycosis was oral anti-fungal drugs such as Fluconazole, Itraconazole and Terbinafine. But many patients were limited to the oral medications due to drug interaction between other CYP P2C9 inhibition such as statins, causing the risk of rhabdomyolysis and hepatotoxicity. Even though these medications are effective against dermatophytes. The non-dermatophytes which were the leading pathogens for onychomycosis in Thailand tends to be resistant to the oral medications. Therefore topical and other modalities have become an important role for treating those non-dermatophytes onychomycosis such as topical anti-fungals, topical urea cream and laser treatment. So far, no standard treatment has been made in order to treat the non-dermatophyte onychomycosis causing problems to both patients and physicians in Thailand.
Amorolfine is a morpholine derivative used in topical anti-fungal that inhibits the biosynthesis of the fungal cell membrane and showed fungicidal activities. From the previous study, amorolfine is an effective topical treatment against non-dermatophyte onychomycosis with 52-55% mycological cure rate and the clinical cure rate varied from 12.7%-54% depending on the studies. The side effects were minimal and the application was simple to use. So amorolfine is used as a first line treatment for non-dermatophyte onychomycosis in our practice. However, with the long treatment (from 6 months up to 1 year) and the low mycological cure rate newer modality had been studied to deal with this problematic pathogens.
Long-pulsed Nd:YAG laser had been used to treat onychomycosis with a promising result. In 2013, Kostas Kalokasidis used long-pulsed Nd:YAG for the onychomycosis and showed a 94.5% mycological cure rate with no relapse of the disease within 3 months. Later on, Rungsima Wanitphakdeedecha M.D. tried the long-pulsed Nd:YAG to treat onychomycosis and found the significant result that long-pulsed Nd:YAG can cure up to 95.42% onychomycosis from non-dermatophyte group. But the protocol was performed the laser treatment every 2 weeks for 1 month which made it difficult for the patient to come to the hospital, moreover the duration to treat onychomycosis might needed to be longer.
So the investigators came up with this study to compare the efficacy of long-pulsed Nd:YAG with 4-week intervals to the amorolfine and the combination of both Nd:YAG and amorolfine to see the mycological result and also the clinical improvement.
The treatment and KOH examination and fungal culture will be performed every month for 4 months, and then the follow up will be at 6 months after the first treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amorolfine | Experimental | Drug: AmorolfineThis group of patients will receive only amorolfine nail lacquer to apply on the affected nail and the KOH examination and fungal culture will be performed every month |
| Long-pulsed Nd:YAG | Experimental | Device: 1,064nm Long-pulsed Nd:YAGThis group of patients will receive only the long-pulsed Nd:YAG (Cynergy®, 5 Carlisle Road Westford, MA USA) fluence 35-45 J/Cm2, spot size 4mm for 2 passes each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month |
| Amorolfine+Long-pulsed Nd:YAG | Experimental | Device: 1,064nm Long-pulsed Nd:YAG, Drug: AmorolfineThis group of patients will receive both amorolfine nail lacquer and the long-pulsed Nd:YAG laser treatment each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients aged more than 18 years old.
- The patients were diagnosed with non-dermatophytes or mixed-infection onychomycosis from both KOH examination and fungal cultured.
- The patients did not have any prior anti-fungal treatment within 6 months
- The patients did not receive any vasodilator drugs or isotretinoin within 6 months
- The patients who are willing to participate, and accept the methods and risk
Key exclusion criteria (6 listed)
- The patients who suffered other medical dermatologic condition associated with onychomycosis such as psoriasis, paronychia etc.
- The patients who took immunosuppressive drugs, or the immunocompromised host.
- The patients who had severe vascular disease, such as severe DVT, or poor capillary refill time.
- The patients who had onychomycosis which involved in nail matrix.
- Pregnancy or lactation.
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 |
|---|---|---|
| 1,064nm Long-pulsed Nd:YAGAlso: Dualis SP; Fotona, LujbljanaLong-pulsed 1,064nm will be used for the treatment of onychomycosis which wll use 35-45 J/cm2 spot size 4, frequency 1 Hz for 2 passes on the infected nails | Device | Amorolfine+Long-pulsed Nd:YAG, Long-pulsed Nd:YAG |
| AmorolfineAmorolfine nail lacquer will be applied by the patient once a week on the infected nails | Drug | Amorolfine, Amorolfine+Long-pulsed Nd:YAG |
Primary outcome
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 6 months after treatment
Mycological cure defined as negative Mycological culture
15 secondary outcomes
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 1 month after treatment
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 2 months after treatment
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 3 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 1 month after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 2 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 3 months after treatment
number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 6 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
Time frame: 1 month after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
Time frame: 2 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
Time frame: 3 months after treatment
pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment
Time frame: 4 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 1 month after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 2 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 3 months after treatment
Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment
Time frame: 6 months after treatment
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 28 Sep 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1,064nm Long-pulsed Nd:YAG and Amorolfine in people with Non-dermatophyte Onychomycosis, run by Mahidol 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 5 inclusion and 6 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 28 Sep 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.