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OnychomycosisPhase 1NCT00941317

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

A Phase 1 study testing Pathformer (micro-drilling device) in people with Onychomycosis, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Onychomycosis
What is being tested?
Pathformer (micro-drilling device)
Type of treatment
Medical device
How many people
25 participants
Where
1 siteUnited States
Study dates
Jul 2009to Sep 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts

Other trials in United States

About this study

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

Read the 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.

Conditions
Onychomycosis
Being tested
Pathformer (micro-drilling device)
Keywords
onychomycosis, micro-drilling
Medical subject headings
Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pathformer (micro-drilling device)Device

    Also called Pathformer

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimize the drilling conditions - to obtain a complete hole and assess tolerability

    Measured: 1 week

Secondary outcomes (1)

  1. The secondary effectiveness objective is to evaluate the overall performance and reliability of the device

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941317
Sponsor's protocol ID
RD.06.CIP.18157
Status last verified
Mar 2011
First submitted
14 Jul 2009
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pathformer (micro-drilling device) in people with Onychomycosis, run by Galderma R&D at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimize the drilling conditions - to obtain a complete hole and assess tolerability (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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