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Treatment of Lower Extremity Spider Veins With Excel V

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ClinicalTrials.gov Identifier: NCT01362192
Recruitment Status : Completed
First Posted : May 30, 2011
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief 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 (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.

Condition or disease Intervention/treatment Phase
Telangiectasis Spider Veins Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011


Arm Intervention/treatment
532 nm KTP Laser Treatment Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.

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
Other Names:
  • Excel V laser
  • ExcelV
  • KTP
  • 532nm




Primary Outcome Measures :
  1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments [ Time Frame: 24 weeks (12 weeks post-final laser treatment) ]

    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%)


Secondary Outcome Measures :
  1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments [ Time Frame: 12 weeks (post-1st laser treatment) ]

    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%)

  2. Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. [ Time Frame: 24 weeks (12 weeks post-final laser treatment) ]

    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%)

  3. Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject. [ Time Frame: 24 weeks (12 weeks post-final laser treatment) ]

    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%)

  4. Percent of Subjects Satisfied With Improvement of Treated Spider Veins. [ Time Frame: 24 weeks (12 weeks post-final laser treatment) ]

    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

  5. Mean Pain Score Associated With Laser Treatment. [ Time Frame: Day 0 (1st 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).

  6. Mean Pain Score Associated With Laser Treatment [ Time Frame: 12 weeks (2nd 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362192


Locations
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United States, Pennsylvania
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States, 19003
Sponsors and Collaborators
Cutera Inc.

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01362192     History of Changes
Other Study ID Numbers: C-11-XLV01
First Posted: May 30, 2011    Key Record Dates
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by Cutera Inc.:
Telangiectasis
Spider Veins
Excel V
Cutera
Laser
Leg Veins
Venulectasia
Lower Extremity veins
Laser light
KTP
532nm
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents