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

August 5, 2013 updated by: Izelda Maria Carvalho Costa, Brasilia University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Federal District
      • Brasilia, Federal District, Brazil, 70910-900
        • Recruiting
        • University Hospital of Brasília
        • Contact:
        • Principal Investigator:
          • Orlando O Morais, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Loceryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Investigators

  • Principal Investigator: Orlando O Morais, M.D., University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 5, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB-UnB OnychoLASER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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