NCT01362192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

May 25, 2011

Results QC Date

June 17, 2013

Last Update Submit

January 26, 2015

Conditions

TelangiectasisSpider Veins

Keywords

TelangiectasisSpider VeinsExcel VCuteraLaserLeg VeinsVenulectasiaLower Extremity veinsLaser lightKTP532nm

Outcome Measures

Primary Outcomes (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%)

    24 weeks (12 weeks post-final laser treatment)

Secondary Outcomes (6)

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

    12 weeks (post-1st laser treatment)

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

    24 weeks (12 weeks post-final laser treatment)

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

    24 weeks (12 weeks post-final laser treatment)

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

    24 weeks (12 weeks post-final laser treatment)

  • Mean Pain Score Associated With Laser Treatment.

    Day 0 (1st laser treatment)

  • +1 more secondary outcomes

Study Arms (1)

532 nm KTP Laser Treatment

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

Interventions

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

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

Also known as: Excel V laser, ExcelV, KTP, 532nm
532 nm KTP Laser Treatment

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Eric F. Bernstein, M.D., M.S.E.
Organization
Main Line Center for Laser Surgery
dermguy@dermguy.com
610-645-5551

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 30, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 29, 2015

Results First Posted

January 29, 2015

Record last verified: 2015-01

Locations

US(1)