Clinical trial NCT01528813: Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis
Official title: AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Onychomycosis
Keywords: Erbium-doped yttrium aluminium garnet laser
Er:YAG
Amorolfine lacquer
Dermatophytes
Subungual distal lateral onychomycosis
Drug delivery
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Extent of nail plate damage
timeFrame: 6 months
Secondary outcomes:
measure: Mycological cure
timeFrame: 6 months
measure: Clinical cure
timeFrame: 6 months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasilia
state: Federal District
Study officials:
affiliation: University of Brasilia
name: Orlando O Morais, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.