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

Phase 2

• Conditions: Onychomycosis
• Interventions: Drug: Amorolfine lacquer

• Registration Number: NCT01528813
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amorolfine lacquer	Amorolfine lacquer	30 ungual units affected by onychomycosis due to dermatophytes

Primary Outcome Measures

Name	Time	Method
Extent of nail plate damage	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

Secondary Outcome Measures

Name	Time	Method
Mycological cure	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
Clinical cure	6 months	After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure

Trial Locations

Locations (1)

University Hospital of Brasilia; 🇧🇷 Brasilia, Federal District, Brazil