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

• ClinicalTrials.gov Identifier: NCT02961634
• Recruitment Status: Unknown
• First Posted: November 11, 2016
• Last Update Posted: March 31, 2017
• Sponsor: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
• Collaborator: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
• Information provided by (Responsible Party): MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

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.

Condition or disease	Intervention/treatment	Phase
Onychomycosis	Device: Nailner 2 in 1; Drug: Ciclopirox 8%	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
• Estimated Study Start Date: April 2017
• Estimated Primary Completion Date: August 2017
• Estimated Study Completion Date: August 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination [ Time Frame: 90 days ]
   Through clinical observation
2. Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire [ Time Frame: 45 and 90 days ]
   Through the patient's subjective evaluation
3. Number of adverse events reported and related to the product investigational [ Time Frame: 90 days ]
   Through the spontaneous report of the patients of events occurred during the study

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ana Carolina Prazias Massei; +55(16)3624-4056; carolina.prazias@mipbrasilfarma.com.br

Sponsors and Collaborators

MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

More Information

• Responsible Party: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
• ClinicalTrials.gov Identifier: NCT02961634
• Other Study ID Numbers: EN16-0467-01
• First Posted: November 11, 2016
• Last Update Posted: March 31, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA:

onychomycosis; nail

Additional relevant MeSH terms:

Onychomycosis; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Skin Diseases; Ciclopirox; Antifungal Agents; Anti-Infective Agents