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

Onychomycosis Clinical Trial

Official title:

AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01528813
• Other study ID #: HUB-UnB OnychoLASER
• Status: Recruiting
• Phase: Phase 2
• First received: February 5, 2012
• Last updated: August 5, 2013
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: Brasilia University Hospital
• Contact: Orlando O Morais, Investigator
• Phone: +55(61)9916-2339
• Email: orlando.unb[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	University Hospital of Brasilia	Brasilia	Federal District

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent 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	6 months	No
Secondary	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	6 months	No
Secondary	Clinical cure	After 6 months of treatment both the group, A and B, will be accessed by dermatological examination to evaluate clinical cure	6 months	No