OnychomycosisEPOCAONNCT00938925
Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)
A study testing Nail lacquer plus aggressive debridement and Nail lacquer alone in people with Onychomycosis, run by University of Malaga at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Nail lacquer plus aggressive debridement and Nail lacquer alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesSpain
- Study dates
- Oct 2009to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
School Health Sciences, University of Malaga
Málaga, Málaga, 29009
Antonio Cuesta-vargas
Málaga, 29009
Health Science School , University of Malaga
Málaga, 29009
About this study
Official title: 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:
Read more
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
- Being tested
- Nail lacquer plus aggressive debridement, Nail lacquer alone
- Keywords
- aggressive debridement, nail lacquer, onychomycosis, podiatry, chiropody, podiatry care
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail lacquer plus aggressive debridementProcedure or surgery
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 aloneProcedure or surgery
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Nail lacquer alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Potassium hydroxide) KOH and cultivation negative
Measured: 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)
Measured: 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)
Measured: 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
Measured: total score, pre and post intervention and 6 and 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2013
- Study completionMar 2017
Why it stopped: No funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Irene Garcia-Paya, DPM, MSc, Principal investigator, University of MalagaJose A Sanchez-Castillo, DPM, MSc, Principal investigator, University of MalagaAntonio I Cuesta-Vargas, PhD, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938925
- Sponsor's protocol ID
- 03-2009
- Acronym
- EPOCAON
- Status last verified
- Mar 2010
- First submitted
- 13 Jul 2009
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00938925
- Acronym / sponsor ID
- EPOCAON / 03-2009
- Conditions
- Onychomycosis
- Keywords
- aggressive debridement, nail lacquer, onychomycosis, podiatry, chiropody, podiatry care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nail lacquer plus aggressive debridement | Experimental | Procedure: Nail lacquer plus aggressive debridementNail 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 | Experimental | Procedure: Nail lacquer aloneNail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nail lacquer plus aggressive debridementNail 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 or surgery | Nail lacquer plus aggressive debridement |
| Nail lacquer aloneNail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care | Procedure or surgery | nail lacqer alone |
Primary outcome
(Potassium hydroxide) KOH and cultivation negative
Time frame: pre and post intervention and 6 and 12 months of follow up
3 secondary outcomes
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- University of MalagaLink provided by the sponsor.
- Regional Panel clinicals trialsLink provided by the sponsor.
- R+D SpainLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Garcia-Paya, DPM, MSc principal investigator
University of Malaga
Jose A Sanchez-Castillo, DPM, MSc principal investigator
University of Malaga
Antonio I Cuesta-Vargas, PhD study director
University of Malaga
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail lacquer plus aggressive debridement and Nail lacquer alone in people with Onychomycosis, run by University of Malaga at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Potassium hydroxide) KOH and cultivation negative (time frame: pre and post intervention and 6 and 12 months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.