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

NCT ID: NCT01528813

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

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.

Conditions

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Onychomycosis

Keywords

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Erbium-doped yttrium aluminium garnet laser Er:YAG Amorolfine lacquer Dermatophytes Subungual distal lateral onychomycosis Drug delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Er:YAG + amorolfine lacquer

30 ungual units affected by onychomycosis due to dermatophytes

Group Type ACTIVE_COMPARATOR

Er:YAG laser + amorolfine lacquer

Intervention Type DEVICE

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.

Amorolfine lacquer

30 ungual units affected by onychomycosis due to dermatophytes

Group Type PLACEBO_COMPARATOR

Amorolfine lacquer

Intervention Type DRUG

To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Other Intervention Names

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Loceryl Er:YAG laser Loceryl

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brasilia University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Izelda Maria Carvalho Costa

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orlando O Morais, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

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University Hospital of Brasilia

Brasília, Federal District, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Orlando O Morais, Investigator

Role: CONTACT

Phone: +55(61)9916-2339

Email: [email protected]

Facility Contacts

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Orlando O Morais, M.D.

Role: primary

References

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Morais OO, Costa IM, Gomes CM, Shinzato DH, Ayres GM, Cardoso RM. The use of the Er:YAG 2940nm laser associated with amorolfine lacquer in the treatment of onychomycosis. An Bras Dermatol. 2013 Sep-Oct;88(5):847-9. doi: 10.1590/abd1806-4841.20131932.

Reference Type DERIVED
PMID: 24173203 (View on PubMed)

Other Identifiers

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HUB-UnB OnychoLASER

Identifier Type: -

Identifier Source: org_study_id