Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

Mazor Robotics

Status and phase: Unknown; Phase 4

Conditions: Onychomycosis

Treatments: Device: CURE-EX device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436291

CURE-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

CURE-EX device

Experimental group

Description:

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

Treatment:

Device: CURE-EX device