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

NCT02754479 | Completed Results FDA Device

• 1 other identifier: C-16-EV07
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.

Conditions

Spider Veins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles

  Four weeks post final laser treatment

Study Arms (1)

Laser treatments

EXPERIMENTAL

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

Device: Nd:YAG laser

Interventions

Nd:YAG laser DEVICE

Treatment of lower extremity spider veins

Also known as: Cutera Excel V

Laser treatments

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 20 to 75 years of age (inclusive).
• Fitzpatrick Skin Type I - III.
• 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.
• Having spider veins on the ankle that are 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 ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
• Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.

You may not qualify if:

• 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 pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kelly Stankiewicz, MD FAAD
• Organization: DuPage Medical Group

kjstanki@gmail.com

(630) 547-5040

Study Officials

• Kelly Stankiewicz, MD FAAD

  DuPage Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: June 10, 2016
• Primary Completion: December 22, 2016
• Study Completion: March 15, 2017
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)