Overview

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.