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

Primary Purpose

Onychomycosis

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nail lacquer plus aggressive debridement
Nail lacquer alone
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring aggressive debridement, nail lacquer, onychomycosis, podiatry, chiropody, podiatry care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School Health Sciences, University of Malaga
  • Antonio Cuesta-vargas
  • Health Science School , University of Malaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nail lacquer plus aggressive debridement

nail lacqer alone

Arm Description

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

Outcomes

Primary Outcome Measures

(Potassium hydroxide) KOH and cultivation negative

Secondary Outcome Measures

Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis)
Quality of life perception related the onychomycosis and foot health by nailQoL and foot health state questionnaire (FHSQ)
Quality of life related general health by euroQol 5-D and SF-12

Full Information

First Posted
July 13, 2009
Last Updated
September 26, 2019
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT00938925
Brief Title
Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)
Acronym
EPOCAON
Official Title
Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Withdrawn
Why Stopped
No funds
Study Start Date
October 2009 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
aggressive debridement, nail lacquer, onychomycosis, podiatry, chiropody, podiatry care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nail lacquer plus aggressive debridement
Arm Type
Experimental
Arm Description
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.
Arm Title
nail lacqer alone
Arm Type
Experimental
Arm Description
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
Intervention Type
Procedure
Intervention Name(s)
Nail lacquer plus aggressive debridement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nail lacquer alone
Intervention Description
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
Primary Outcome Measure Information:
Title
(Potassium hydroxide) KOH and cultivation negative
Time Frame
pre and post intervention and 6 and 12 months of follow up
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Garcia-Paya, DPM, MSc
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose A Sanchez-Castillo, DPM, MSc
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio I Cuesta-Vargas, PhD
Organizational Affiliation
University of Malaga
Official's Role
Study Director
Facility Information:
Facility Name
School Health Sciences, University of Malaga
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Antonio Cuesta-vargas
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Health Science School , University of Malaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.uma.es/
Description
University of Malaga
URL
http://www.juntadeandalucia.es/salud/principal/documentos.asp?pagina=ec_op1
Description
Regional Panel clinicals trials
URL
http://www.plannacionalidi.es/plan-idi-public/
Description
R+D Spain

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Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)

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