OnychomycosisNCT02445495
Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
An observational study of Onychomycosis, run by Jason K Rivers, MD, FRCPC, FAAD.
Trial summary
The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- GenesisPlus 1064 nm Nd:YAG laser
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2014
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 participants at primary clinic
Who may be able to join
- Male or Female subjects, age 18 to 80 years (inclusive).
- Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
- Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
- Subject has baseline and post treatment digital photographs of target great toenails.
- Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.
Who cannot join
- Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
- Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
- Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
- Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
- Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
- Subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final Cutera® GenesisPlus laser treatment.
- Subjects who were pregnant or breastfeeding.
About this study
Official title: A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.
Read the detailed description
This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.
- Conditions
- Onychomycosis
- Being tested
- GenesisPlus 1064 nm Nd:YAG laser
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenesisPlus 1064 nm Nd:YAG laserDevice
Also called Cutera®
Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
change in % of infected toenail involvement
onychomycosis involvement
Measured: change from baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason K Rivers, MD, FRCPC, FAAD
- Sponsor type
- University, hospital or other
- Collaborators
- Cutera Inc.
- Responsible party
- Sponsor-investigator, Jason K Rivers, MD, FRCPC, FAAD, Pacific Dermaesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445495
- Sponsor's protocol ID
- PDA288
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT02445495
- Acronym / sponsor ID
- PDA288
- Conditions
- Onychomycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jason K Rivers, MD, FRCPC, FAADUniversity, hospital or other
- Collaborators
- Cutera Inc.
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
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 determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.
Detailed description
This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 participants at primary clinic
Key inclusion criteria (5 listed)
- Male or Female subjects, age 18 to 80 years (inclusive).
- Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
- Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
- Subject has baseline and post treatment digital photographs of target great toenails.
- Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.
Key exclusion criteria (7 listed)
- Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
- Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
- Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
- Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
- Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
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 |
|---|---|---|
| GenesisPlus 1064 nm Nd:YAG laserAlso: Cutera®Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis | Device | – |
Primary outcome
change in % of infected toenail involvement
Time frame: change from baseline up to 6 months
onychomycosis involvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Onychomycosis, run by Jason K Rivers, MD, FRCPC, FAAD.
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 5 inclusion and 7 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
change in % of infected toenail involvement (time frame: change from baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2015.