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

2014-08-27 03:20:41 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Onychomycosis

Intervention

Pathformer (micro-drilling device)

Location

Massachusetts General Hospital
Boston
Massachusetts
United States

Status

Completed

Source

Galderma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:41-0400

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