Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

Phase 4

• Conditions: Onychomycosis
• Interventions: Device: CURE-EX device

• Registration Number: NCT02436291
• Lead Sponsor: MB Mazor Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2014-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CURE-EX device	CURE-EX device	twice daily treatment with CURE-EX device for 24-30 weeks

Primary Outcome Measures

Name	Time	Method
Nail cure as measured by measured by length of healthy nail of at least 5 mm	24-30 weeks	Cure measured by length of healthy nail of at least 5 mm
Nail cure as measured by culture and smear	24-30 weeks	Nail culture and smear

Trial Locations

Locations (1)

Lev Yasmin Clinic; 🇮🇱 Natanya, Israel