Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis

Study Overview
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Brief Summary
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The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.

Detailed Description
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This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design. Therefore, each nail out of two from a single patient will be randomized into the following study arms: Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months. Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months. At the end of 6 months the data from both groups, A and B, regarding *clinical cure, *mycological cure and *extent of damage to the nail plates will be analyzed using specific tests.

Official Title
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AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE

Conditions
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Onychomycosis

Intervention / Treatment
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* Device: Er:YAG laser + amorolfine lacquer
* Drug: Amorolfine lacquer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-60 year-old preserved cognitive status direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds Exclusion Criteria: diabetes type 1 or 2; peripheral vascular disease having undergone any treatment in the last 6 months peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc) willing to paint nail during the study high blood pressure use of any immunosuppressive drugs; congenital or acquired immunodeficiency

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Er:YAG + amorolfine lacquer<br>30 ungual units affected by onychomycosis due to dermatophytes | Device: Er:YAG laser + amorolfine lacquer<br>* To each compromised ungual unit randomly assigned to this group it will be applied a single session of Er:YAG laser to the ungual lamina in the beginning of study. Onwards, amorolfine lacquer will be applied weekly for a period of 06 months.<br>* Other names: Er:YAG laser;|
| Placebo Comparator: Amorolfine lacquer<br>30 ungual units affected by onychomycosis due to dermatophytes | Drug: Amorolfine lacquer<br>* To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.<br>* Other names: Loceryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of nail plate damage | At the beginning and after 6 months of treatment both the group, A and B, will have the length from nail cuticle to the closest point of damage to the nail plate measured by a millimeter scale. It will later be accessed to determine the clearance rate of the nail plate achieved with each treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological cure | After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure | 6 months | 
| Clinical cure | After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erbium-doped yttrium aluminium garnet laser, Er:YAG, Amorolfine lacquer, Dermatophytes, Subungual distal lateral onychomycosis, Drug delivery