Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)

NCT ID: NCT00938925

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nail lacquer plus aggressive debridement

Intervention Type: PROCEDURE

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 lacqer alone

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

Group Type: EXPERIMENTAL

Nail lacquer alone

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Nail lacquer alone

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Garcia-Paya, DPM, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Jose A Sanchez-Castillo, DPM, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Antonio I Cuesta-Vargas, PhD

Role: STUDY_DIRECTOR

University of Malaga

Locations

School Health Sciences, University of Malaga

Málaga, Málaga, Spain

Antonio Cuesta-vargas

Málaga, , Spain

Health Science School , University of Malaga

Málaga, , Spain

Countries

Spain

Related Links

http://www.uma.es/

University of Malaga

http://www.juntadeandalucia.es/salud/principal/documentos.asp?pagina=ec_op1

Regional Panel clinicals trials

http://www.plannacionalidi.es/plan-idi-public/

R+D Spain

Other Identifiers

03-2009

Identifier Type: -

Identifier Source: org_study_id