Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
NCT Number: NCT02812043
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bangkoknoi, Bangkok, 10700, Thailand
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Dualis SP; Fotona, Lujbljana
Amorolfine nail lacquer will be applied by the patient once a week on the infected nails
Time frame: 6 months after treatment
Mycological cure defined as negative Mycological culture
Time frame: 1 month after treatment
Mycological cure rate
Time frame: 2 months after treatment
Mycological cure rate
Time frame: 3 months after treatment
Mycological cure rate
Time frame: 1 month after treatment
number of participants
Time frame: 2 months after treatment
number of participants
Time frame: 3 months after treatment
number of participants
Time frame: 6 months after treatment
number of participants
Time frame: 1 month after treatment
pain score
Time frame: 2 months after treatment
pain score
Time frame: 3 months after treatment
pain score
Time frame: 4 months after treatment
pain score
Time frame: 1 month after treatment
Depth of nail
Time frame: 2 months after treatment
Depth of nail
Time frame: 3 months after treatment
Depth of nail
Time frame: 6 months after treatment
Depth of nail
Mahidol University
Other
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
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