Spider Veins
Conditions
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.
Interventions
DEVICENd:YAG laser
Treatment of lower extremity spider veins
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females, 20 to 75 years of age (inclusive). 2. Fitzpatrick Skin Type I - III. 3. 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. 4. Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator. 5. Subject must be able to read, understand and sign the Informed Consent Form. 6. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. 7. Wiling to have limited sun exposure for the duration of the study, including the follow-up period. 8. Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes. 9. Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.
Exclusion criteria
1. Fitzpatrick Skin Type IV - VI. 2. Pregnant. 3. Having an infection, dermatitis or a rash in the treatment area. 4. Having significant varicosities or perforator veins. 5. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. 6. Systemic use of isotretinoin (Accutane®) within 6 months of study participation. 7. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles | 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
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatments Each subject will receive a combination of 532 nm \\and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Laser Treatments |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Time frame: Four weeks post final laser treatment.
Population: 1 enrolled participant was lost to follow-up prior to receiving treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatments | Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles | 3.7 score on a scale | Standard Deviation 0.6 |
Secondary
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.
Time frame: Four weeks post final laser treatment
Population: 1 enrolled participant was lost to follow-up prior to receiving treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatments | Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles | 4.3 score on a scale | Standard Deviation 1.2 |