Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) (EPOCAON)

September 26, 2019 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain, 29009
        • Antonio Cuesta-Vargas
      • Malaga, Spain, 29009
        • Health Science School , University of Malaga
    • Málaga
      • Malaga, Málaga, Spain, 29009
        • School Health Sciences, University of Malaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nail lacquer plus aggressive debridement
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 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.
Experimental: nail lacqer alone
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
Procedure: Nail lacquer alone
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
(Potassium hydroxide) KOH and cultivation negative
Time Frame: pre and post intervention and 6 and 12 months of follow up
pre and post intervention and 6 and 12 months of follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis)
Time Frame: total score, pre and post intervention and 6 and 12 months of follow up
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)
Time Frame: total score, pre and post intervention and 6 and 12 months of follow up
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
Time Frame: total score, pre and post intervention and 6 and 12 months of follow up
total score, pre and post intervention and 6 and 12 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Irene Garcia-Paya, DPM, MSc, University of Malaga
  • Principal Investigator: Jose A Sanchez-Castillo, DPM, MSc, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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