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TelangiectasisPhase 4NCT01362192

Treatment of Lower Extremity Spider Veins With Excel V

A Phase 4 study testing 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. in people with Telangiectasis and Spider Veins, run by Cutera Inc. 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

The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet… Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Telangiectasis, Spider Veins
What is being tested?
532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2011to Nov 2011
Phase
Phase 4
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 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Fitzpatrick Skin Type I - III
  • Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins
  • Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator
  • Having lower extremity spider veins 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 lower extremity spider veins
  • Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study
  • Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments
  • For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study

Who cannot join

  • Having received any prior laser treatment for lower extremity spider veins
  • 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 keloid scarring, hypertrophic scarring or of abnormal wound healing
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  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
  • History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
  • Having a known anticoagulative condition or taking anticoagulation medications
  • History of thromboembolic disease, such as deep vein thrombosis (DVT)
  • History of seizure disorders due to light
  • Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen
  • Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
  • Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy
  • Undergoing systemic chemotherapy for the treatment of cancer
  • Systemic use of isotretinoin (Accutane®) within 6 months of study participation
  • Any use of gold therapy for disorders such as rheumatologic disease or lupus
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
  • Participation in a study of another device or drug within three months prior to enrollment or during the study
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Main Line Center for Laser Surgery

    Ardmore, Pennsylvania, 19003

Other trials in United States

About this study

Official title: A Clinical Evaluation of the Treatment of Lower Extremity Spider Veins Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy

The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.

Read the detailed description

Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.

Being tested
532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Keywords
Telangiectasis, Spider Veins, Excel V, Cutera, Laser, Leg Veins, Venulectasia, Lower Extremity veins, Laser light, KTP, 532nm
Medical subject headings
Telangiectasis

What participants receive

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

  • 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.Device

    Also called Excel V laser, ExcelV, KTP, 532nm

    The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows:

    • Spot Size: 5 mm
    • Fluence: 13-15 J/cm2
    • Pulse Duration: 40 ms
    • Epidermal contact-cooling: 5° Celsius
Study groups in NCT01362192
Study groupRoleWhat they receive
532 nm KTP Laser TreatmentOtherNot described
Receives: Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.

What is being measured

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

  1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments

    A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:

    • 0 = No Improvement (0%)
    • 1 = Mild Improvement (< 25%)
    • 2 = Moderate Improvement (26 to 50%)
    • 3 = Significant Improvement (51 to 75%)
    • 4 = Very Significant Improvement (76 to 100%)

    Measured: 24 weeks (12 weeks post-final laser treatment)

Secondary outcomes (6)

  1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments

    The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:

    • 0 = No Improvement (0%)
    • 1 = Mild Improvement (< 25%)
    • 2 = Moderate Improvement (26 to 50%)
    • 3 = Significant Improvement (51 to 75%)
    • 4 = Very Significant Improvement (76 to 100%)

    Measured: 12 weeks (post-1st laser treatment)

  2. Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.

    The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:

    • 0 = No Improvement (0%)
    • 1 = Mild Improvement (< 25%)
    • 2 = Moderate Improvement (26 to 50%)
    • 3 = Significant Improvement (51 to 75%)
    • 4 = Very Significant Improvement (76 to 100%)

    Measured: 24 weeks (12 weeks post-final laser treatment)

  3. Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.

    Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:

    • 0 = No Improvement (0%)
    • 1 = Mild Improvement (< 25%)
    • 2 = Moderate Improvement (26 to 50%)
    • 3 = Significant Improvement (51 to 75%)
    • 4 = Very Significant Improvement (76 to 100%)

    Measured: 24 weeks (12 weeks post-final laser treatment)

  4. Percent of Subjects Satisfied With Improvement of Treated Spider Veins.

    Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:

    • 1 = Very Much Not Satisfied
    • 2 = Not Satisfied
    • 3 = Somewhat Satisfied
    • 4 = Satisfied
    • 5 = Very Much Satisfied

    Measured: 24 weeks (12 weeks post-final laser treatment)

  5. Mean Pain Score Associated With Laser Treatment.

    Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).

    Measured: Day 0 (1st laser treatment)

  6. Mean Pain Score Associated With Laser Treatment

    Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).

    Measured: 12 weeks (2nd laser treatment)

Timeline

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

  1. First posted30 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362192
Sponsor's protocol ID
C-11-XLV01
Status last verified
Jan 2015
First submitted
25 May 2011
Last updated
29 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. in people with Telangiectasis and 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 11 inclusion and 21 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 29 Jan 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2015). 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?

Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments (time frame: 24 weeks (12 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?

On the ClinicalTrials.gov record for NCT01362192.

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 29 Jan 2015.

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