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

Brasilia University Hospital

Status and phase: Unknown; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Amorolfine lacquer; Device: Er:YAG laser + amorolfine lacquer

Study type: Interventional

Funder types: Other

Identifiers

NCT01528813

HUB-UnB OnychoLASER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups, including a placebo group

Er:YAG + amorolfine lacquer

Active Comparator group

Description:

30 ungual units affected by onychomycosis due to dermatophytes

Treatment:

Device: Er:YAG laser + amorolfine lacquer

Amorolfine lacquer

Placebo Comparator group

Description:

30 ungual units affected by onychomycosis due to dermatophytes

Treatment:

Drug: Amorolfine lacquer