Spider VeinsNCT02754479
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
A study testing Nd:YAG laser in people with Spider Veins, run by Cutera Inc. at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spider Veins
- What is being tested?
- Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2016to 15 Mar 2017
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, 20 to 75 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator.
- Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
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- Wiling to have limited sun exposure for the duration of the study, including the follow-up period.
- Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
- Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.
Who cannot join
- Fitzpatrick Skin Type IV - VI.
- Pregnant.
- Having an infection, dermatitis or a rash in the treatment area.
- Having significant varicosities or perforator veins.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of the Treatment of Spider Veins on the Ankles Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
Read the detailed description
The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.
- Conditions
- Spider Veins
- Being tested
- Nd:YAG laser
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laserDevice
Also called Cutera Excel V
Treatment of lower extremity spider veins
| Study group | Role | What they receive |
|---|---|---|
| Laser treatments | Experimental | Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment Receives: Device: Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles
Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome.
Measured: Four weeks post final laser treatment.
Secondary outcomes (1)
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles
Subject satisfaction with improvement in spider veins on the ankles as assessed using the Subject Satisfaction Assessment scale (Min=1, Max=5) at 4 weeks post final treatment. Higher score indicates better outcome.
Measured: Four weeks post final laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start10 Jun 2016
- Primary completion22 Dec 2016
- Study completion15 Mar 2017
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.
- Other trials for Spider VeinsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly Stankiewicz, MD FAAD, Principal investigator, DuPage Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754479
- Sponsor's protocol ID
- C-16-EV07
- Status last verified
- May 2023
- First submitted
- 25 Apr 2016
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Treatment of Spider Veins on the Ankles Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
- ClinicalTrials.gov ID
- NCT02754479
- Acronym / sponsor ID
- C-16-EV07
- Conditions
- Spider Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
Detailed description
The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatments | Experimental | Device: Nd:YAG laserEach subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females, 20 to 75 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator.
- Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
- Subject must be able to read, understand and sign the Informed Consent Form.
Key exclusion criteria (8 listed)
- Fitzpatrick Skin Type IV - VI.
- Pregnant.
- Having an infection, dermatitis or a rash in the treatment area.
- Having significant varicosities or perforator veins.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
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 |
|---|---|---|
| Nd:YAG laserAlso: Cutera Excel VTreatment of lower extremity spider veins | Device | Laser treatments |
Primary outcome
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles
Time frame: Four weeks post final laser treatment.
Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome.
1 secondary outcome
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles
Time frame: Four weeks post final laser treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Spider Veins
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Varicose Veins of Lower Limb, Spider Veins
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.
Kelly Stankiewicz, MD FAAD principal investigator
DuPage Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser in people with Spider Veins, run by Cutera Inc. 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 8 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 9 May 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2023). 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?
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles (time frame: Four weeks post final laser treatment.). 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 9 May 2023.