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

NCT ID: NCT02754479

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-10
• Study Completion Date: 2017-03-15

Brief Summary

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.

Conditions

Spider Veins

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser treatments

Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment

Group Type: EXPERIMENTAL

Nd:YAG laser

Intervention Type: DEVICE

Treatment of lower extremity spider veins

Interventions

Nd:YAG laser

Treatment of lower extremity spider veins

Intervention Type: DEVICE

Other Intervention Names

Cutera Excel V

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Stankiewicz, MD FAAD

Role: PRINCIPAL_INVESTIGATOR

DuPage Medical Group

Locations

DuPage Medical Group

Naperville, Illinois, United States

Countries

United States

Other Identifiers

C-16-EV07

Identifier Type: -

Identifier Source: org_study_id