Clinical Evaluation of the Treatment of Spider Angioma

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

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

Study Overview

• Status: Completed
• Conditions: Spider Angioma
• Intervention / Treatment: Device: KTP laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• 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: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females, 5 to 65 years of age (inclusive).
2. Fitzpatrick Skin Types I-IV
3. Subject must be able to read, understand and sign the Informed Consent Form.
4. 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.
5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
6. Willing to have limited sun exposure for the duration of the study, including the follow-up period.
7. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
8. Agree not to undergo any other procedure for the treatment of spider angioma during the study.

Exclusion Criteria:

1. Pregnant.
2. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
3. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
4. History of seizure disorders due to light.
5. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
6. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
7. Participation in a study of another device or drug within 3 months prior to enrollment or 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 treatment; Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).	Device: KTP laser; Dual Wavelength Laser Emitting 532 nm Laser Energy; Other Names: Cutera Excel V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Assessment Scale for Improvement of Spider Angioma	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: 0. None; Mild; Moderate; Significant; Very Significant; Complete Removal	Four weeks post laser treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At 4 weeks post-final treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale.	Subject satisfaction assessment of laser outcome and procedure at 4 weeks post-final treatment	Four weeks post laser treatment.

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2016
• Primary Completion (Actual): January 13, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma
• Other Study ID Numbers: C-16-EV08

Plan for Individual participant data (IPD)

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