Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Single-blind Evaluation of Device Performance and Tolerability to Nail Micro-drilling in Subjects With Onychomycosis|
- Optimize the drilling conditions - to obtain a complete hole and assess tolerability [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- The secondary effectiveness objective is to evaluate the overall performance and reliability of the device [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Device: Pathformer (micro-drilling device)
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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|Principal Investigator:||Alexa B. Kimball, MD, MPH||Massachusetts General Hospital, Boston, MA, USA|