Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pathformer (micro-drilling device)
Sponsored by
About this trial
This is an interventional other trial for Onychomycosis focused on measuring onychomycosis, micro-drilling
Eligibility Criteria
Inclusion Criteria:
- The subject is a male or female 18 years of age or older with clinical diagnosis of distolateral onychomycosis without matrix involvement in at least one big toe with a nail plate at least 2 cm wide. Note: This diagnosis will be based on clinical signs and microscopy; no laboratory culture is required.
- The total disease involvement will be at least 30% and no more than 70% of the total surface of the 1 or 2 big toenail(s) to be drilled in order to allow drilling of up to 5 holes spaced at least 3 mm apart, 5 mm from the lunula, and 2 mm from the lateral edge in each affected and unaffected part of the nail(s).
- The subject is willing and able to comply with the requirements of the CIP and visit schedule. In particular, subjects must agree to remove and not reapply any nail polish or related products to the target toenails for the duration of the study
- The subject understands that this is a drug-free device study for which no therapeutic benefit is expected.
- The subject must agree not to file, clip, or otherwise disturb the target toenail between study visits
- The subject agrees to participate in the study and authorize photographs taken per study requirements, verified by dating and signing an approved written Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures
- The subject is a female of non-childbearing potential (defined as post-menopausal [absence of menstrual bleeding for 1 year prior to enrollment], hysterectomy or bilateral oophorectomy) or if the subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at the baseline visit
Exclusion Criteria:
- Affected toenail(s) distal edge of the toenail plate more than 4 mm thick. The distance from the affected distal edge of the toenail plate to the toenail bed will be measured by using a ruler or caliper.
- The subject has other clinically significant nail disease, including clinical signs of nail psoriasis, nail discoloration of nail trauma, or paronychia of the target toenail(s)
- Signs of infection (other than fungal) in one of the feet, including the contralateral foot
- The subject takes daily pain medication, including anti-inflammatory and corticosteroid medications at doses that relieve pain
- The subject takes anti-coagulants (e.g., heparin, warfarin) at therapeutic doses. Prophylactic anti-coagulant therapy (for example inhibitors of platelet aggregation, low dose aspirin, or low molecular weight heparin) is permitted.
- The subject has proximal subungual onychomycosis or only superficial nail plate onychomycosis
- The subject has immunodeficiency, peripheral neuropathy, or peripheral vascular disease, or known types 1 or 2 diabetes.
- The subject has another underlying known disease, a surgical or medical condition that, in the opinion of the Investigator, might interfere with interpretation of the study results
- The subject is currently enrolled in another investigational drug or device study OR participated in such a study in the past 3 months prior to Visit 1 OR in an exclusion period from a previous study
- A female subject is pregnant or plans to conceive a child within 1 month
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
Optimize the drilling conditions - to obtain a complete hole and assess tolerability
Secondary Outcome Measures
The secondary effectiveness objective is to evaluate the overall performance and reliability of the device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00941317
Brief Title
Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
Official Title
A Single-blind Evaluation of Device Performance and Tolerability to Nail Micro-drilling in Subjects With Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
onychomycosis, micro-drilling
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pathformer (micro-drilling device)
Other Intervention Name(s)
Pathformer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optimize the drilling conditions - to obtain a complete hole and assess tolerability
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The secondary effectiveness objective is to evaluate the overall performance and reliability of the device
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject is a male or female 18 years of age or older with clinical diagnosis of distolateral onychomycosis without matrix involvement in at least one big toe with a nail plate at least 2 cm wide. Note: This diagnosis will be based on clinical signs and microscopy; no laboratory culture is required.
The total disease involvement will be at least 30% and no more than 70% of the total surface of the 1 or 2 big toenail(s) to be drilled in order to allow drilling of up to 5 holes spaced at least 3 mm apart, 5 mm from the lunula, and 2 mm from the lateral edge in each affected and unaffected part of the nail(s).
The subject is willing and able to comply with the requirements of the CIP and visit schedule. In particular, subjects must agree to remove and not reapply any nail polish or related products to the target toenails for the duration of the study
The subject understands that this is a drug-free device study for which no therapeutic benefit is expected.
The subject must agree not to file, clip, or otherwise disturb the target toenail between study visits
The subject agrees to participate in the study and authorize photographs taken per study requirements, verified by dating and signing an approved written Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures
The subject is a female of non-childbearing potential (defined as post-menopausal [absence of menstrual bleeding for 1 year prior to enrollment], hysterectomy or bilateral oophorectomy) or if the subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at the baseline visit
Exclusion Criteria:
Affected toenail(s) distal edge of the toenail plate more than 4 mm thick. The distance from the affected distal edge of the toenail plate to the toenail bed will be measured by using a ruler or caliper.
The subject has other clinically significant nail disease, including clinical signs of nail psoriasis, nail discoloration of nail trauma, or paronychia of the target toenail(s)
Signs of infection (other than fungal) in one of the feet, including the contralateral foot
The subject takes daily pain medication, including anti-inflammatory and corticosteroid medications at doses that relieve pain
The subject takes anti-coagulants (e.g., heparin, warfarin) at therapeutic doses. Prophylactic anti-coagulant therapy (for example inhibitors of platelet aggregation, low dose aspirin, or low molecular weight heparin) is permitted.
The subject has proximal subungual onychomycosis or only superficial nail plate onychomycosis
The subject has immunodeficiency, peripheral neuropathy, or peripheral vascular disease, or known types 1 or 2 diabetes.
The subject has another underlying known disease, a surgical or medical condition that, in the opinion of the Investigator, might interfere with interpretation of the study results
The subject is currently enrolled in another investigational drug or device study OR participated in such a study in the past 3 months prior to Visit 1 OR in an exclusion period from a previous study
A female subject is pregnant or plans to conceive a child within 1 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa B. Kimball, MD, MPH
Organizational Affiliation
Massachusetts General Hospital, Boston, MA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
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