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

NCT02961634 | Unknown Phase 3

• 1 other identifier: EN16-0467-01
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination

  90 days

• Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire

  45 and 90 days

• Number of adverse events reported and related to the product investigational

  90 days

Study Arms (2)

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.

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.

Drug: Ciclopirox 8%

Interventions

Nailner 2 in 1 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.

Nailner 2 in 1 + Ciclopirox 8%

Ciclopirox 8% DRUG

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

Ciclopirox 8%; Nailner 2 in 1 + Ciclopirox 8%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ana Carolina Prazias Massei

CONTACT

+55(16)3624-4056; carolina.prazias@mipbrasilfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 11, 2016
• Study Start: April 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share