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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brasilia University Hospital
• Treatments: Amorolfine

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