NCT01528813

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

February 5, 2012

Last Update Submit

August 5, 2013

Conditions

Onychomycosis

Keywords

Erbium-doped yttrium aluminium garnet laserEr:YAGAmorolfine lacquerDermatophytesSubungual distal lateral onychomycosisDrug delivery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Mycological cure

    6 months

  • Clinical cure

    6 months

Study Arms (2)

Er:YAG + amorolfine lacquer

ACTIVE COMPARATOR

30 ungual units affected by onychomycosis due to dermatophytes

Device: Er:YAG laser + amorolfine lacquer

Amorolfine lacquer

PLACEBO COMPARATOR

30 ungual units affected by onychomycosis due to dermatophytes

Drug: Amorolfine lacquer

Interventions

Er:YAG laser + amorolfine lacquerDEVICE

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.

Also known as: Loceryl, Er:YAG laser
Er:YAG + amorolfine lacquer
Amorolfine lacquerDRUG

To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.

Also known as: Loceryl
Amorolfine lacquer

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • year-old
  • preserved cognitive status
  • direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Brasilia

Brasília, Federal District, 70910-900, Brazil

RECRUITING

Related Publications (1)

  • Morais OO, Costa IM, Gomes CM, Shinzato DH, Ayres GM, Cardoso RM. The use of the Er:YAG 2940nm laser associated with amorolfine lacquer in the treatment of onychomycosis. An Bras Dermatol. 2013 Sep-Oct;88(5):847-9. doi: 10.1590/abd1806-4841.20131932.

    PMID: 24173203DERIVED

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers, Solid-Stateamorolfine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Orlando O Morais, M.D.

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orlando O Morais, Investigator

CONTACT

+55(61)9916-2339orlando.unb@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

February 5, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

BR(1)