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Clinical Evaluation of the Treatment of Spider Angioma

Primary Purpose

Spider Angioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KTP laser
Sponsored by
Cutera Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spider Angioma

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • DuPage Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser treatment

Arm Description

Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 25, 2016
Last Updated
February 27, 2023
Sponsor
Cutera Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02755467
Brief Title
Clinical Evaluation of the Treatment of Spider Angioma
Official Title
A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
January 13, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spider Angioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser treatment
Arm Type
Experimental
Arm Description
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
Intervention Type
Device
Intervention Name(s)
KTP laser
Other Intervention Name(s)
Cutera Excel V
Intervention Description
Dual Wavelength Laser Emitting 532 nm Laser Energy
Primary Outcome Measure Information:
Title
Physician's Global Assessment Scale for Improvement of Spider Angioma
Description
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
Time Frame
Four weeks post laser treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Stankiewicz, MD FAAD
Organizational Affiliation
DuPage Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of the Treatment of Spider Angioma

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