Onychomycosis
Conditions
Keywords
onychomycosis, nail
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.
Interventions
DEVICENailner 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.
DRUGCiclopirox 8%
Ciclopirox 8% is a glaze used in the treatment of onychomycosis
Sponsors
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90 | 90 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination | 90 days | Through clinical observation |
| Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire | 45 and 90 days | Through the patient's subjective evaluation |
| Number of adverse events reported and related to the product investigational | 90 days | Through the spontaneous report of the patients of events occurred during the study |
Contacts
Primary ContactAna Carolina Prazias Massei
Outcome results
None listed