Onychomycosis of ToenailsNCT01920178
Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis
A study testing PinPointe Foot Laser in people with Onychomycosis of Toenails, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis of Toenails
- What is being tested?
- PinPointe Foot Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous treatment with at least 90 days of oral Terbinafine and completed the treatment at least 1 year ago
- Able to feel a Semmes-Weinstein monofilament at the tip of each toe
- Must have at least 50% involvement in at least one great toenail
- Must be willing and able to present for one treatment visit and two follow-up visits at 6 months and 12 months following initial treatment to photograph the nails
- Must be willing to apply topical antifungal to the skin surrounding the toes on a daily basis and be willing to spray shoes with an aerosolized antifungal on a weekly basis
- Must have dystrophic toenails which clinically appear to be mycotic
Show all 9Show fewer
- Age ≥ 18 years and ≤ 70 years
- Willing to comply with study requirements, including regular nail debridement as indicated by the investigator
- Willing to provide informed consent to participate
Who cannot join
- Evidence of gangrene or non-palpable dorsalis pedis and posterior tibial pulses
- Capillary refill time greater than 5 seconds
- Patients who are severely immunocompromised (such as in AIDS, renal transplant regimens, immunosuppressed states consequent to malignancy or agents used in rendering oncologic care, or who suffer from end stage renal disease)
- Patients with documented diagnosis of psoriasis or lichen planus
- Actively treating fungal nails with a topical agent during the last 90 days prior to enrollment, including tea tree oil, antifungal nail polish, Penlac, fungoid tincture, or similar over-the-counter antifungal treatments
- Inability to follow treatment regimen or comply with follow-up schedules
Show all 10Show fewer
- History of malignant melanoma or any forms of skin cancers
- Evidence of acute bacterial infections with or without cellulitis and/or purulence
- Treatment for onychocryptosis during the last 30 days or a history of recurrent onychocryptosis of at least 3 episodes in the last 12 months in which medical care such as resection by a podiatrist/physician, or use of antibiotics was rendered
- Toenail deformity associated with trauma, psoriasis or lichen planus
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
About this study
Official title: A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
Read the detailed description
This protocol is designed to demonstrate that the PinPointe FootLaser treatment is able to produce clinical improvement treating onychomycosis in patients who have previously taken Terbinafine and failed treatment. The duration of enrollment for each subject will be 2 years, with the expectation that this is the time period that will yield 100% reduction in the area of involved nail. Enrollment is competitive and we expect to enroll 40 patients at CHA.
The medical device that is the subject of this clinical trial is the PinPointe FootLaser, manufactured by NuvoLase, Inc. It is a pulsed Nd:Yag laser device that uses a proprietary pulse train, operating at 1064nm wavelength, with 100 μsec pulses. It received pre-market Section 510(k) clearance by the FDA and subsequent clearance for the treatment of onychomycosis in 2010.
Onychomycosis (OM), a fungal infection of the toes, is a major health problem around the world. It is estimated that there are more than 40 million sufferers with this condition in the USA. A recent European study showed that the prevalence of onychomycosis may be as high as 26.9%. Importantly, it is a particular problem that disproportionately affects diabetics. The main causative agent varies according to climate. Dermatophyte infections are common worldwide.
Preliminary in vitro and in vivo work has demonstrated the proof of principle that the PinPointe FootLaser device can kill microorganisms, including dermatophytes and other fungi, which infect the toenail. Based on these preliminary results, this study has been designed to demonstrate the efficacy and safety of the PinPointe FootLaser for clearing toenails, including those with onychomycosis.
- Conditions
- Onychomycosis of Toenails
- Being tested
- PinPointe Foot Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinPointe Foot LaserDevice
Active Laser Treatment Group will receive active Pinpointe Foot Laser beam. Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser
| Study group | Role | What they receive |
|---|---|---|
| PinPointe Foot Laser | Active comparator | Active laser Receives: Device: PinPointe Foot Laser |
| Sham laser group | Sham comparator | Treatment with only localizing (aiming) beam of Pinpointe Foot Laser Receives: Device: PinPointe Foot Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.
Measured: 12 months
Secondary outcomes (1)
Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Onychomycosis of ToenailsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul M Heffernan, D.P.M., Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920178
- Sponsor's protocol ID
- 0860/08/11
- Status last verified
- Jul 2016
- First submitted
- 7 Aug 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arrese JE, Pierard GE. Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. doi: 10.1159/000073086.
PubMed 14571066Elewski BE, Scher RK, Aly R, Daniel R 3rd, Jones HE, Odom RB, Zaias N, Jacko ML. Double-blind, randomized comparison of itraconazole capsules vs. placebo in the treatment of toenail onychomycosis. Cutis. 1997 Apr;59(4):217-20.
PubMed 9104548Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000 Oct;43(4 Suppl):S70-80. doi: 10.1067/mjd.2000.109071.
PubMed 11051136Haneke E, Abeck D, Ring J. Safety and efficacy of intermittent therapy with itraconazole in finger- and toenail onychomycosis: a multicentre trial. Mycoses. 1998 Dec;41(11-12):521-7. doi: 10.1111/j.1439-0507.1998.tb00716.x.
PubMed 9919897Pollak R, Billstein SA. Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations. J Am Podiatr Med Assoc. 2001 Mar;91(3):127-31. doi: 10.7547/87507315-91-3-127.
PubMed 11266494Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A. The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52. doi: 10.1080/09546630600965004.
PubMed 17373090Scher RK, Tavakkol A, Sigurgeirsson B, Hay RJ, Joseph WS, Tosti A, Fleckman P, Ghannoum M, Armstrong DG, Markinson BC, Elewski BE. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44. doi: 10.1016/j.jaad.2006.12.019. Epub 2007 Feb 16.
PubMed 17307276
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis
- ClinicalTrials.gov ID
- NCT01920178
- Acronym / sponsor ID
- 0860/08/11
- Conditions
- Onychomycosis of Toenails
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
Detailed description
This protocol is designed to demonstrate that the PinPointe FootLaser treatment is able to produce clinical improvement treating onychomycosis in patients who have previously taken Terbinafine and failed treatment. The duration of enrollment for each subject will be 2 years, with the expectation that this is the time period that will yield 100% reduction in the area of involved nail. Enrollment is competitive and we expect to enroll 40 patients at CHA.
The medical device that is the subject of this clinical trial is the PinPointe FootLaser, manufactured by NuvoLase, Inc. It is a pulsed Nd:Yag laser device that uses a proprietary pulse train, operating at 1064nm wavelength, with 100 μsec pulses. It received pre-market Section 510(k) clearance by the FDA and subsequent clearance for the treatment of onychomycosis in 2010.
Onychomycosis (OM), a fungal infection of the toes, is a major health problem around the world. It is estimated that there are more than 40 million sufferers with this condition in the USA. A recent European study showed that the prevalence of onychomycosis may be as high as 26.9%. Importantly, it is a particular problem that disproportionately affects diabetics. The main causative agent varies according to climate. Dermatophyte infections are common worldwide.
Preliminary in vitro and in vivo work has demonstrated the proof of principle that the PinPointe FootLaser device can kill microorganisms, including dermatophytes and other fungi, which infect the toenail. Based on these preliminary results, this study has been designed to demonstrate the efficacy and safety of the PinPointe FootLaser for clearing toenails, including those with onychomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PinPointe Foot Laser | Active comparator | Device: PinPointe Foot LaserActive laser |
| Sham laser group | Sham comparator | Device: PinPointe Foot LaserTreatment with only localizing (aiming) beam of Pinpointe Foot Laser |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Previous treatment with at least 90 days of oral Terbinafine and completed the treatment at least 1 year ago
- Able to feel a Semmes-Weinstein monofilament at the tip of each toe
- Must have at least 50% involvement in at least one great toenail
- Must be willing and able to present for one treatment visit and two follow-up visits at 6 months and 12 months following initial treatment to photograph the nails
- Must be willing to apply topical antifungal to the skin surrounding the toes on a daily basis and be willing to spray shoes with an aerosolized antifungal on a weekly basis
Key exclusion criteria (10 listed)
- Evidence of gangrene or non-palpable dorsalis pedis and posterior tibial pulses
- Capillary refill time greater than 5 seconds
- Patients who are severely immunocompromised (such as in AIDS, renal transplant regimens, immunosuppressed states consequent to malignancy or agents used in rendering oncologic care, or who suffer from end stage renal disease)
- Patients with documented diagnosis of psoriasis or lichen planus
- Actively treating fungal nails with a topical agent during the last 90 days prior to enrollment, including tea tree oil, antifungal nail polish, Penlac, fungoid tincture, or similar over-the-counter antifungal treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PinPointe Foot LaserActive Laser Treatment Group will receive active Pinpointe Foot Laser beam. Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser | Device | PinPointe Foot Laser, Sham laser group |
Primary outcome
Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.
Time frame: 12 months
1 secondary outcome
Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14571066Arrese JE, Pierard GE. Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. doi: 10.1159/000073086.
- Background: PubMed 9104548Elewski BE, Scher RK, Aly R, Daniel R 3rd, Jones HE, Odom RB, Zaias N, Jacko ML. Double-blind, randomized comparison of itraconazole capsules vs. placebo in the treatment of toenail onychomycosis. Cutis. 1997 Apr;59(4):217-20.
- Background: PubMed 11051136Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000 Oct;43(4 Suppl):S70-80. doi: 10.1067/mjd.2000.109071.
- Background: PubMed 9919897Haneke E, Abeck D, Ring J. Safety and efficacy of intermittent therapy with itraconazole in finger- and toenail onychomycosis: a multicentre trial. Mycoses. 1998 Dec;41(11-12):521-7. doi: 10.1111/j.1439-0507.1998.tb00716.x.
- Background: PubMed 11266494Pollak R, Billstein SA. Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations. J Am Podiatr Med Assoc. 2001 Mar;91(3):127-31. doi: 10.7547/87507315-91-3-127.
- Background: PubMed 17373090Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A. The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52. doi: 10.1080/09546630600965004.
- Background: PubMed 17307276Scher RK, Tavakkol A, Sigurgeirsson B, Hay RJ, Joseph WS, Tosti A, Fleckman P, Ghannoum M, Armstrong DG, Markinson BC, Elewski BE. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44. doi: 10.1016/j.jaad.2006.12.019. Epub 2007 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M Heffernan, D.P.M. principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PinPointe Foot Laser in people with Onychomycosis of Toenails, run by Cambridge Health Alliance 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 9 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: stopped early, as of the sponsor's last update on 30 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator. (time frame: 12 months). 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 NCT01920178, which also lists 7 linked publications.
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 30 May 2017.