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Completed

NCT Number: NCT02754479

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

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

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DuPage Medical Group

Naperville, Illinois, 60563, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Nd:Yag Laser

Device

Treatment of lower extremity spider veins

Other names: Cutera Excel V

Primary outcomes

  1. Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles

    Time frame: Four weeks post final laser treatment.

    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.

Secondary outcomes

  1. Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles

    Time frame: Four weeks post final laser treatment

    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.

Sponsors and collaborators

Lead sponsor

Cutera Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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