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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

Current Primary Outcome: Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90 [ Time Frame: 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)


Original Primary Outcome: Percent improvement of nail injury caused by onychomycosis [ Time Frame: 90 days ]

Current Secondary Outcome:

  • Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination [ Time Frame: 90 days ]
    Through clinical observation
  • Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire [ Time Frame: 45 and 90 days ]
    Through the patient's subjective evaluation
  • Number of adverse events reported and related to the product investigational [ Time Frame: 90 days ]
    Through the spontaneous report of the patients of events occurred during the study


Original Secondary Outcome:

  • Presence of fungal structures in nail affected by onychomycosis in visits 1 and final [ Time Frame: 90 days ]
  • Number of patients reporting reduction in discomfort caused by onychomycosis [ Time Frame: 45 and 90 days ]
  • Number of adverse events reported and related to the product investigational [ Time Frame: 90 days ]


Information By: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

Dates:
Date Received: November 7, 2016
Date Started: April 2017
Date Completion: August 2017
Last Updated: March 30, 2017
Last Verified: March 2017