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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Brasilia University Hospital
Sponsor:
Information provided by (Responsible Party):
Izelda Maria Carvalho Costa, Brasilia University Hospital
ClinicalTrials.gov Identifier:
NCT01528813
First received: February 5, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Onychomycosis
Device: Er:YAG laser + amorolfine lacquer
Drug: Amorolfine lacquer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Brasilia University Hospital:

Primary Outcome Measures:
  • Extent of nail plate damage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Mycological cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure

  • Clinical cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528813

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

Locations
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
Principal Investigator: Orlando O Morais, M.D. University of Brasilia
  More Information

No publications provided by Brasilia University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: February 5, 2012
Last Updated: August 5, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Nail Diseases
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Amorolfine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014