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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02961634
• Other study ID #: EN16-0467-01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 7, 2016
• Last updated: March 30, 2017
• Start date: April 2017
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
• Contact: Ana Carolina Prazias Massei
• Phone: +55(16)3624-4056
• Email: carolina.prazias[@]mipbrasilfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA	Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	90 days
Secondary	Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination	Through clinical observation	90 days
Secondary	Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire	Through the patient's subjective evaluation	45 and 90 days
Secondary	Number of adverse events reported and related to the product investigational	Through the spontaneous report of the patients of events occurred during the study	90 days