Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

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 Overview

• Status: Unknown
• Conditions: Onychomycosis
• Intervention / Treatment: Device: Nailner 2 in 1; Drug: Ciclopirox 8%

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ana Carolina Prazias Massei; Phone Number: +55(16)3624-4056; Email: carolina.prazias@mipbrasilfarma.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nailner 2 in 1 + 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.	Device: Nailner 2 in 1; 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.; Drug: Ciclopirox 8%; Ciclopirox 8% is a glaze used in the treatment of onychomycosis
Active Comparator: 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.	Drug: Ciclopirox 8%; Ciclopirox 8% is a glaze used in the treatment of onychomycosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination	Through clinical observation	90 days
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire	Through the patient's subjective evaluation	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	90 days

Collaborators and Investigators

• Sponsor: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
• Collaborators: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: onychomycosis; nail
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Anti-Infective Agents; Antifungal Agents; Ciclopirox
• Other Study ID Numbers: EN16-0467-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No