OnychomycosisPhase 3NCT02961634
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
A Phase 3 study testing Nailner 2 in 1 and Ciclopirox 8% in people with Onychomycosis, run by MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA.
Trial summary
Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Nailner 2 in 1 and Ciclopirox 8%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Aug 2017
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes;
- Volunteers aged 18-65 years;
- Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
- Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
- Understand, consent and sign the Instrument of Consent of Clarified.
Who cannot join
- Pregnancy or risk pregnancy / lactation;
- Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- Concomitant nail pathologies (psoriasis, lichen planus, etc.);
- Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
- Irritation History to similar products to the investigational product;
- Treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks);
- Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.
- Conditions
- Onychomycosis
- Being tested
- Nailner 2 in 1, Ciclopirox 8%
- Keywords
- onychomycosis, nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nailner 2 in 1Device
Nailner 2 in 1 is a combination of assets that alter the pH of the nail and is used as an adjunct in the treatment of onychomycosis.
Ciclopirox 8%Drug
Ciclopirox 8% is a glaze used in the treatment of onychomycosis
| Study group | Role | What they receive |
|---|---|---|
| Nailner 2 in 1 + Ciclopirox 8% | Experimental | Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail.
They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. Receives: Device: Nailner 2 in 1; Drug: Ciclopirox 8% |
| Ciclopirox 8% | Active comparator | Patients should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. Receives: Drug: Ciclopirox 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
The improvement rate will be by measuring the area of the nail affected in millimeters (millimeters). The measurement will be taken with a ruler in the direction of the width and length of the lesion (mm2)
Measured: 90 days
Secondary outcomes (3)
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
Through clinical observation
Measured: 90 days
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
Through the patient's subjective evaluation
Measured: 45 and 90 days
Number of adverse events reported and related to the product investigational
Through the spontaneous report of the patients of events occurred during the study
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startApr 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961634
- Sponsor's protocol ID
- EN16-0467-01
- Status last verified
- Mar 2017
- First submitted
- 7 Nov 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
- ClinicalTrials.gov ID
- NCT02961634
- Acronym / sponsor ID
- EN16-0467-01
- Conditions
- Onychomycosis
- Keywords
- onychomycosis, nail
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDAIndustry (pharma, biotech, devices)
- Collaborators
- Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
- Study start
- Apr 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 11 Nov 2016 (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.
Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nailner 2 in 1 + Ciclopirox 8% | Experimental | Device: Nailner 2 in 1, Drug: Ciclopirox 8%Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail. They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. |
| Ciclopirox 8% | Active comparator | Drug: Ciclopirox 8%Patients should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers of both sexes;
- Volunteers aged 18-65 years;
- Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
- Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
- Understand, consent and sign the Instrument of Consent of Clarified.
Key exclusion criteria (7 listed)
- Pregnancy or risk pregnancy / lactation;
- Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- Concomitant nail pathologies (psoriasis, lichen planus, etc.);
- Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
- Irritation History to similar products to the investigational product;
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 |
|---|---|---|
| Nailner 2 in 1Nailner 2 in 1 is a combination of assets that alter the pH of the nail and is used as an adjunct in the treatment of onychomycosis. | Device | Nailner 2 in 1 + Ciclopirox 8% |
| Ciclopirox 8%Ciclopirox 8% is a glaze used in the treatment of onychomycosis | Drug | Ciclopirox 8%, Nailner 2 in 1 + Ciclopirox 8% |
Primary outcome
Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
Time frame: 90 days
The improvement rate will be by measuring the area of the nail affected in millimeters (millimeters). The measurement will be taken with a ruler in the direction of the width and length of the lesion (mm2)
3 secondary outcomes
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
Time frame: 90 days
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
Time frame: 45 and 90 days
Number of adverse events reported and related to the product investigational
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nailner 2 in 1 and Ciclopirox 8% in people with Onychomycosis, run by MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA.
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 5 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: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Carolina Prazias Massei (+55(16)3624-4056, carolina.prazias@mipbrasilfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90 (time frame: 90 days). 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 31 Mar 2017.