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Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis

NCT00941317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-02-17

No results posted yet for this study

Summary

Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affected parts of the nail. The aim of this study is to determine the optimal drilling condition that could be used in future studies of this device in combination with topical treatment for onychomycosis.

Conditions

  • Onychomycosis

Interventions

DEVICE

Pathformer (micro-drilling device)

The micro-drilling device drills the nail with a prespecified diameter drill bit and to a prespecified depth in the nail, using skin impedance (also referred to as equivalent resistivity level) as a feedback mechanism for stopping the drilling intervention at a preset trigger level value.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Alexa B. Kimball, MD, MPH · Massachusetts General Hospital, Boston, MA, USA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941317 on ClinicalTrials.gov