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

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.