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

NCT ID: NCT02961634

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2017-08-31

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.

Conditions

Onychomycosis

Keywords

onychomycosis; nail

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nailner 2 in 1

Intervention Type: DEVICE

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%

Intervention Type: DRUG

Ciclopirox 8% is a glaze used in the treatment of onychomycosis

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.

Group Type: ACTIVE_COMPARATOR

Ciclopirox 8%

Intervention Type: DRUG

Ciclopirox 8% is a glaze used in the treatment of onychomycosis

Interventions

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.

Intervention Type: DEVICE

Ciclopirox 8%

Ciclopirox 8% is a glaze used in the treatment of onychomycosis

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

INDUSTRY

Sponsor Role: collaborator

MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ana Carolina Prazias Massei

Role: CONTACT

Phone: +55(16)3624-4056

Email: carolina.prazias@mipbrasilfarma.com.br

Other Identifiers

EN16-0467-01

Identifier Type: -

Identifier Source: org_study_id