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OpenTrials
Completed

NCT Number: NCT02755467

Clinical Evaluation of the Treatment of Spider Angioma

To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

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Key information

Conditions

Age range

5 year–65 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 safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or females, 5 to 65 years of age (inclusive).
  • Fitzpatrick Skin Types I-IV
  • Subject must be able to read, understand and sign the Informed Consent Form.
  • If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
  • Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Willing to have limited sun exposure for the duration of the study, including the follow-up period.
  • Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
  • Agree not to undergo any other procedure for the treatment of spider angioma during the study.

Exclusion criteria

  • Pregnant.
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  • Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
  • History of seizure disorders due to light.
  • 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.
  • Participation in a study of another device or drug within 3 months prior to enrollment or 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

KTP laser

Device

Dual Wavelength Laser Emitting 532 nm Laser Energy

Other names: Cutera Excel V

Primary outcomes

  1. Physician's Global Assessment Scale for Improvement of Spider Angioma

    Time frame: Four weeks post laser treatment.

    Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale.

    High scores indicate better outcomes:

    • None
    • Mild
    • Moderate
    • Significant
    • Very Significant
    • Complete Removal

Sponsors and collaborators

Lead sponsor

Cutera Inc.

Industry

Registry information

Official study title

A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Mar 24, 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.