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

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ClinicalTrials.gov Identifier: NCT01528813
Recruitment Status : Unknown
Verified August 2013 by Izelda Maria Carvalho Costa, Brasilia University Hospital.
Recruitment status was:  Recruiting
First Posted : February 8, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Izelda Maria Carvalho Costa, Brasilia University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Onychomycosis Device: Er:YAG laser + amorolfine lacquer Drug: Amorolfine lacquer Phase 2

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE
Study Start Date : February 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Er:YAG + amorolfine lacquer
30 ungual units affected by onychomycosis due to dermatophytes
 Device: Er:YAG laser + amorolfine lacquer
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.
Other Names:
  • Loceryl
  • Er:YAG laser
Placebo Comparator: Amorolfine lacquer
30 ungual units affected by onychomycosis due to dermatophytes
 Drug: Amorolfine lacquer
To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.
Other Name: Loceryl


Outcome Measures
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Primary Outcome Measures :
  1. Extent of nail plate damage [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Mycological cure [ Time Frame: 6 months ]
    After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure

  2. Clinical cure [ Time Frame: 6 months ]
    After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01528813


Contacts
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Contact: Orlando O Morais, Investigator +55(61)9916-2339 orlando.unb@gmail.com

Locations
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Brazil
University Hospital of Brasilia Recruiting
Brasilia, Federal District, Brazil, 70910-900
Contact: Orlando O Morais, M.D.    +55(61)99162339    orlando.unb@gmail.com   
Principal Investigator: Orlando O Morais, M.D.         
Sponsors and Collaborators
Brasilia University Hospital
Investigators
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Principal Investigator: Orlando O Morais, M.D. University of Brasilia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT01528813     History of Changes
Other Study ID Numbers: HUB-UnB OnychoLASER
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Izelda Maria Carvalho Costa, Brasilia University Hospital:
Erbium-doped yttrium aluminium garnet laser
Er:YAG
Amorolfine lacquer
 Dermatophytes
Subungual distal lateral onychomycosis
Drug delivery

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