NCT00938925

Brief Summary

Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and quality of life of the patient. Although the investigators have a wide therapeutic arsenal, there is still a disparity when carrying out an effective processing. Hypothesis/Objectives: To analyze if the use of the podiatric technique of aggressive unguinal abrasion with micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray, significantly increases the effectiveness clinically as well as mycology. The investigators will analyze the relationship between this intervention and the quality perception of life related to the health of the nails and the foot. The investigators will Use results for next validation study in Spanish of the questionnaire NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness of the processing. Method: The investigators will design a randomized control trial. The town will be recruited, informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with sample size of 313 patients. There will be a screening of 4 weeks to select patients with onychomycosis infections (clinic and mycology both positives); later the patients will be distributed randomly in 2 groups:

  • GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12 and 24, followed by standard treatment of amorolfin 5%, two weekly applications during 36 weeks.
  • GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according to common format. The duration will be 48 weeks.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 30, 2019

Status Verified

March 1, 2010

Enrollment Period

4.2 years

First QC Date

July 13, 2009

Last Update Submit

September 26, 2019

Conditions

Onychomycosis

Keywords

aggressive debridementnail lacqueronychomycosispodiatrychiropodypodiatry care

Outcome Measures

Primary Outcomes (1)

  • (Potassium hydroxide) KOH and cultivation negative

    pre and post intervention and 6 and 12 months of follow up

Secondary Outcomes (3)

  • Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis)

    total score, pre and post intervention and 6 and 12 months of follow up

  • Quality of life perception related the onychomycosis and foot health by nailQoL and foot health state questionnaire (FHSQ)

    total score, pre and post intervention and 6 and 12 months of follow up

  • Quality of life related general health by euroQol 5-D and SF-12

    total score, pre and post intervention and 6 and 12 months of follow up

Study Arms (2)

Nail lacquer plus aggressive debridement

EXPERIMENTAL

Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.

Procedure: Nail lacquer plus aggressive debridement

nail lacqer alone

EXPERIMENTAL

Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care

Procedure: Nail lacquer alone

Interventions

Nail lacquer plus aggressive debridementPROCEDURE

Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.

Nail lacquer plus aggressive debridement
Nail lacquer alonePROCEDURE

Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care

nail lacqer alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People of both sexes with ages between 18 and 75 years.
  • Having affected at least the nail out of the first toe of a foot.
  • Having a confirmed diagnosis of onychomycosis with positive and evidence clinic mycology (KOH and Cultivation) both positive ones.
  • The infection should be caused by a fungus dermatology. Will not afford another type of infection because of the possibility of false positives for pollution exogen.

You may not qualify if:

  • Having received in 6 previous months some local treatment or systemic for the onychomycosis.
  • Having dystrophies or alterations ungulates, apart from the ones specific to the onychomycosis, that could to interfere in the interpretation of results.
  • Do not have skills for the application and tracking of the topical treatment with the hairspray ungual.
  • Allergy to one of the ingredients of the nail lacquer
  • Pregnancy or breastfeeding situation acquaintances at the time of recruitment.
  • Use of some abrasive or cosmetic product (ej: nail paint) on the treated nail during the tracking of the study.
  • Receiving some type of attendance podology or of Pedicure out of the own ones included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

School Health Sciences, University of Malaga

Málaga, Málaga, 29009, Spain

Location

Antonio Cuesta-vargas

Málaga, 29009, Spain

Location

Health Science School , University of Malaga

Málaga, 29009, Spain

Location

Related Links

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Irene Garcia-Paya, DPM, MSc

    University of Malaga

    PRINCIPAL INVESTIGATOR

  • Jose A Sanchez-Castillo, DPM, MSc

    University of Malaga

    PRINCIPAL INVESTIGATOR

  • Antonio I Cuesta-Vargas, PhD

    University of Malaga

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

March 1, 2017

Last Updated

September 30, 2019

Record last verified: 2010-03

Locations

ES(3)