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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-blind Evaluation of Device Performance and Tolerability to Nail Micro-drilling in Subjects With Onychomycosis

Brief 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.

Detailed Summary:

This drug-free, single-blind device study will evaluate the completeness of the holes and the tolerability (pain) of the drilling process by testing several trigger levels. Subjects with distolateral onychomycosis will have a series of holes drilled into the unaffected and affected areas of 1 or 2 big toenail(s). A pain level < 4 using the subject self-assessment Numeric Rating Scale (NRS) is considered as acceptable with regard to the study procedure.

The study will use a two-cohort design in subjects with distolateral onychomycosis.

Sponsor: Galderma

Current Primary Outcome: Optimize the drilling conditions - to obtain a complete hole and assess tolerability [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary effectiveness objective is to evaluate the overall performance and reliability of the device [ Time Frame: 1 day ]

Original Secondary Outcome: Same as current

Information By: Galderma

Dates:
Date Received: July 14, 2009
Date Started: July 2009
Date Completion:
Last Updated: March 25, 2011
Last Verified: March 2011