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Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis

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ClinicalTrials.gov Identifier: NCT02812043
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief 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.

Condition or disease Intervention/treatment Phase
Non-dermatophyte Onychomycosis Device: 1,064nm Long-pulsed Nd:YAG Drug: Amorolfine Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Amorolfine
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
Drug: Amorolfine
Amorolfine nail lacquer will be applied by the patient once a week on the infected nails

Experimental: Long-pulsed Nd:YAG
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
Device: 1,064nm Long-pulsed Nd:YAG
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 Name: Dualis SP; Fotona, Lujbljana

Experimental: Amorolfine+Long-pulsed Nd:YAG
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
Device: 1,064nm Long-pulsed Nd:YAG
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 Name: Dualis SP; Fotona, Lujbljana

Drug: Amorolfine
Amorolfine nail lacquer will be applied by the patient once a week on the infected nails




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  2. Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  3. Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  4. number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  5. number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  6. number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  7. number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 6 months after treatment ]
  8. pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  9. pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  10. pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  11. pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 4 months after treatment ]
  12. Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  13. Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  14. Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  15. Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 6 months after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The patients aged more than 18 years old.
  2. The patients were diagnosed with non-dermatophytes or mixed-infection onychomycosis from both KOH examination and fungal cultured.
  3. The patients did not have any prior anti-fungal treatment within 6 months
  4. The patients did not receive any vasodilator drugs or isotretinoin within 6 months
  5. The patients who are willing to participate, and accept the methods and risk

Exclusion Criteria:

  1. The patients who suffered other medical dermatologic condition associated with onychomycosis such as psoriasis, paronychia etc.
  2. The patients who took immunosuppressive drugs, or the immunocompromised host.
  3. The patients who had severe vascular disease, such as severe DVT, or poor capillary refill time.
  4. The patients who had onychomycosis which involved in nail matrix.
  5. Pregnancy or lactation.
  6. The patients who had problems communication or have difficulty travel to the faculty for the checkup.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812043


Locations
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Thailand
Department of Dermatology Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Charussri Leeyaphan, MD    6624194333    charussrilee@gmail.com   
Sponsors and Collaborators
Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02812043     History of Changes
Other Study ID Numbers: 391/2558(EC1)
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Mahidol University:
onychomycosis
amorolfine
long-pulsed Nd:YAG
fungal infection
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Antifungal Agents
Anti-Infective Agents