- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00941317
Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
A Single-blind Evaluation of Device Performance and Tolerability to Nail Micro-drilling in Subjects With Onychomycosis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Optimize the drilling conditions - to obtain a complete hole and assess tolerability
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary effectiveness objective is to evaluate the overall performance and reliability of the device
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexa B. Kimball, MD, MPH, Massachusetts General Hospital, Boston, MA, USA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD.06.CIP.18157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Onychomycosis
-
Vésale HospitalJanssen-Cilag Ltd.CompletedPrevalence of Onychomycosis | Diabetic Neuropathic Patients | Diagnostic of Onychomycosis | Patients Clinically Suspected of Onychomycosis | Reliability of the Diagnosis of OnychomycosisBelgium
-
University of Alabama at BirminghamDUSA Pharmaceuticals, Inc.CompletedToenail Onychomycosis | Distal and Lateral Subungual Toenail OnychomycosisUnited States
-
DeviceFarm, Inc.Symbio, LLC; Center for Dermatology Clinical Research, Inc.CompletedOnychomycosis Due to Trichophyton Rubrum | Onychomycosis Due to Trichophyton MentagrophytesUnited States
-
Janssen Korea, Ltd., KoreaCompleted
-
ToeFX Inc.Active, not recruiting
-
SATO Pharmaceutical Co., Ltd.Active, not recruitingOnychomycosis of ToenailUnited States
-
Mahidol UniversityCompletedNon-dermatophyte OnychomycosisThailand
-
Oystershell NVCompletedOnychomycosis of ToenailTunisia
-
Moberg Pharma ABCompletedDistal Subungual OnychomycosisUnited States, Canada
-
PfizerCompletedOnychomycosis of ToenailsUnited States, Canada
Clinical Trials on Pathformer (micro-drilling device)
-
Cytrellis Biosystems, Inc.Completed
-
St. Luke's-Roosevelt Hospital CenterCompletedBrain Arteriovenous Malformation | Brain Vascular Malformations | Vein of Galen MalformationUnited States
-
Sanoculis LtdNot yet recruitingPrimary Open Angle Glaucoma | Open Angle Glaucoma
-
Coloplast A/SCompletedUrinary Incontinence | Retention, UrinaryDenmark
-
Coloplast A/SCompletedUrinary RetentionFrance, Denmark, Germany, United Kingdom
-
Medtronic Cardiac Rhythm and Heart FailureCompletedHeart FailureBelgium, Germany, United Kingdom, Italy, Slovakia
-
C. R. BardCompletedEmbolization, TherapeuticUnited States
-
C. R. BardCompletedEmbolization, TherapeuticAustralia, New Zealand
-
VA Office of Research and DevelopmentRecruitingMild Traumatic Brain Injury | PhotophobiaUnited States
-
School of Health Sciences GenevaCompletedWound Heal | Chronic WoundSwitzerland