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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
46
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.
Ciclopirox 8% is a glaze used in the treatment of onychomycosis
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)
Time frame: 90 days
Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
Through clinical observation
Time frame: 90 days
Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
Through the patient's subjective evaluation
Time frame: 45 and 90 days
Number of adverse events reported and related to the product investigational
Through the spontaneous report of the patients of events occurred during the study
Time frame: 90 days
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