A Clinical Evaluation of the Treatment of Spider Veins on the Ankles

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.

Study Overview

• Status: Completed
• Conditions: Spider Veins
• Intervention / Treatment: Device: Nd:YAG laser

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • DuPage Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males or females, 20 to 75 years of age (inclusive).
2. Fitzpatrick Skin Type I - III.
3. 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.
4. Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
5. Subject must be able to read, understand and sign the Informed Consent Form.
6. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
7. Wiling to have limited sun exposure for the duration of the study, including the follow-up period.
8. Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
9. Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.

Exclusion Criteria:

1. Fitzpatrick Skin Type IV - VI.
2. Pregnant.
3. Having an infection, dermatitis or a rash in the treatment area.
4. Having significant varicosities or perforator veins.
5. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
6. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
7. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser treatments; Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment	Device: Nd:YAG laser; Treatment of lower extremity spider veins; Other Names: Cutera Excel V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks post final laser treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks post final laser treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Kelly Stankiewicz, MD FAAD, DuPage Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Telangiectasis
• Other Study ID Numbers: C-16-EV07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No