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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.
University Hospital of Brasilia
Brasília, Federal District, Brazil
RECRUITINGExtent of nail plate damage
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
Time frame: 6 months
Mycological cure
After 6 months of treatment both the group, A and B, will be accessed by direct mycological examination and culture to evaluate mycological cure
Time frame: 6 months
Clinical cure
After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure
Time frame: 6 months
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