Back to resultsStudy Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nailner 2 in 1
Ciclopirox 8%
Sponsored by
About this trial
This is an interventional supportive care trial for Onychomycosis focused on measuring onychomycosis, nail
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nailner 2 in 1 + Ciclopirox 8%
Ciclopirox 8%
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
Through clinical observation
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
Through the patient's subjective evaluation
Number of adverse events reported and related to the product investigational
Through the spontaneous report of the patients of events occurred during the study
Full Information
NCT ID
NCT02961634
First Posted
November 7, 2016
Last Updated
March 30, 2017
Sponsor
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Collaborators
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
1. Study Identification
Unique Protocol Identification Number
NCT02961634
Brief Title
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Official Title
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Collaborators
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
onychomycosis, nail
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nailner 2 in 1 + Ciclopirox 8%
Arm Type
Experimental
Arm Description
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.
Arm Title
Ciclopirox 8%
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nailner 2 in 1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ciclopirox 8%
Intervention Description
Ciclopirox 8% is a glaze used in the treatment of onychomycosis
Primary Outcome Measure Information:
Title
Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
Description
Through clinical observation
Time Frame
90 days
Title
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
Description
Through the patient's subjective evaluation
Time Frame
45 and 90 days
Title
Number of adverse events reported and related to the product investigational
Description
Through the spontaneous report of the patients of events occurred during the study
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Carolina Prazias Massei
Phone
+55(16)3624-4056
Email
carolina.prazias@mipbrasilfarma.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
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