Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961634
Recruitment Status : Unknown
Verified March 2017 by MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
Information provided by (Responsible Party):
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA

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.

Condition or disease Intervention/treatment Phase
Onychomycosis Device: Nailner 2 in 1 Drug: Ciclopirox 8% Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nailner 2 in 1 + Ciclopirox 8%

Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail.

They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun.

Device: Nailner 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.

Drug: Ciclopirox 8%
Ciclopirox 8% is a glaze used in the treatment of onychomycosis

Active Comparator: Ciclopirox 8%
Patients should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun.
Drug: Ciclopirox 8%
Ciclopirox 8% is a glaze used in the treatment of onychomycosis




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination [ Time Frame: 90 days ]
    Through clinical observation

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961634


Contacts
Layout table for location contacts
Contact: Ana Carolina Prazias Massei +55(16)3624-4056 carolina.prazias@mipbrasilfarma.com.br

Sponsors and Collaborators
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

Layout table for additonal information
Responsible Party: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
ClinicalTrials.gov Identifier: NCT02961634     History of Changes
Other Study ID Numbers: EN16-0467-01
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA:
onychomycosis
nail
Additional relevant MeSH terms:
Layout table for MeSH terms
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents