Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

Onychomycosis Clinical Trial

Official title:

Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436291
• Other study ID #: CURE-01
• Status: Recruiting
• Phase: Phase 4
• First received: April 28, 2015
• Last updated: May 5, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: MB Mazor Ltd.
• Contact: Ofer Mazor
• Phone: 972-52-8566789
• Email: ofmazor[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Description:

Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).

2. Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.

3. Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.

Exclusion Criteria:

1. lunula infected with onychomycosis.

2. Pregnant or breast feeding female.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• CURE-EX device
Treatment with CURE-EX device twice daily for 24-30 weeks.

Locations

Country	Name	City	State
Israel	Lev Yasmin Clinic	Natanya

Sponsors (1)

Lead Sponsor	Collaborator
MB Mazor Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nail cure as measured by measured by length of healthy nail of at least 5 mm	Cure measured by length of healthy nail of at least 5 mm	24-30 weeks	No
Primary	Nail cure as measured by culture and smear	Nail culture and smear	24-30 weeks	No