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

MIP Brasil Indústria e Comércio de Produtos Farmacêuticos

Status and phase: Unknown; Phase 3

Conditions: Onychomycosis

Treatments: Device: Nailner 2 in 1; Drug: Ciclopirox 8%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02961634

EN16-0467-01

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Nailner 2 in 1 + Ciclopirox 8%

Experimental group

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.

Treatment:

Device: Nailner 2 in 1

Drug: Ciclopirox 8%

Ciclopirox 8%

Active Comparator group

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.

Treatment:

Drug: Ciclopirox 8%