Back to resultsA Clinical Evaluation of the Treatment of Spider Veins on the Ankles
Primary Purpose
Spider Veins
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nd:YAG laser
Sponsored by
About this trial
This is an interventional treatment trial for Spider Veins
Eligibility Criteria
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.
Sites / Locations
- DuPage Medical Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser treatments
Arm Description
Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02754479
Brief Title
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2016 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spider Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser treatments
Arm Type
Experimental
Arm Description
Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment
Intervention Type
Device
Intervention Name(s)
Nd:YAG laser
Other Intervention Name(s)
Cutera Excel V
Intervention Description
Treatment of lower extremity spider veins
Primary Outcome Measure Information:
Title
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles
Description
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.
Time Frame
Four weeks post final laser treatment.
Secondary Outcome Measure Information:
Title
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles
Description
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.
Time Frame
Four weeks post final laser treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
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