Spider Veins, Telangiectasis
Conditions
Keywords
Telangiectasis, Spider Veins, Excel V, Cutera, Laser, Leg Veins, Venulectasia, Lower Extremity veins, Laser light, KTP, 532nm
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.
Detailed description
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.
Interventions
DEVICE532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows: * Spot Size: 5 mm * Fluence: 13-15 J/cm2 * Pulse Duration: 40 ms * Epidermal contact-cooling: 5° Celsius
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Fitzpatrick Skin Type I - III * Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins * Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator * Having lower extremity spider veins 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 lower extremity spider veins * Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study * Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments * For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study
Exclusion criteria
* Having received any prior laser treatment for lower extremity spider veins * 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 keloid scarring, hypertrophic scarring or of abnormal wound healing * History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications * History of connective tissue disease, such as systemic lupus erythematosus or scleroderma * History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation * Having a known anticoagulative condition or taking anticoagulation medications * History of thromboembolic disease, such as deep vein thrombosis (DVT) * History of seizure disorders due to light * Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen * Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely) * Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy * Undergoing systemic chemotherapy for the treatment of cancer * Systemic use of isotretinoin (Accutane®) within 6 months of study participation * Any use of gold therapy for disorders such as rheumatologic disease or lupus * 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 three months prior to enrollment or during the study * As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | 24 weeks (12 weeks post-final laser treatment) | A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. | 24 weeks (12 weeks post-final laser treatment) | The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%) |
| Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject. | 24 weeks (12 weeks post-final laser treatment) | Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%) |
| Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | 12 weeks (post-1st laser treatment) | The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%) |
| Mean Pain Score Associated With Laser Treatment. | Day 0 (1st laser treatment) | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). |
| Mean Pain Score Associated With Laser Treatment | 12 weeks (2nd laser treatment) | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). |
| Percent of Subjects Satisfied With Improvement of Treated Spider Veins. | 24 weeks (12 weeks post-final laser treatment) | Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: * 1 = Very Much Not Satisfied * 2 = Not Satisfied * 3 = Somewhat Satisfied * 4 = Satisfied * 5 = Very Much Satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 532 nm KTP Laser Treatment Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | 532 nm KTP Laser Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 48 years |
| Fitzpatrick Skin Type I | 1 participants |
| Fitzpatrick Skin Type II | 15 participants |
| Fitzpatrick Skin Type III | 4 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 24 weeks (12 weeks post-final laser treatment)
Population: per protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 532 nm KTP Laser Treatment | Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | 2.5 points on Improvement scale |
Secondary
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 12 weeks (post-1st laser treatment)
Population: per protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 532 nm KTP Laser Treatment | Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | 1.8 points on Improvement scale |
Secondary
Mean Pain Score Associated With Laser Treatment
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time frame: 12 weeks (2nd laser treatment)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 532 nm KTP Laser Treatment | Mean Pain Score Associated With Laser Treatment | 2.5 Numeric Pain Rating Score | Standard Deviation 0.9 |
Secondary
Mean Pain Score Associated With Laser Treatment.
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time frame: Day 0 (1st laser treatment)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 532 nm KTP Laser Treatment | Mean Pain Score Associated With Laser Treatment. | 3.2 Numeric Pain Rating Score | Standard Deviation 1 |
Secondary
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: * 1 = Very Much Not Satisfied * 2 = Not Satisfied * 3 = Somewhat Satisfied * 4 = Satisfied * 5 = Very Much Satisfied
Time frame: 24 weeks (12 weeks post-final laser treatment)
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 532 nm KTP Laser Treatment | Percent of Subjects Satisfied With Improvement of Treated Spider Veins. | 100 percent of participants |
Secondary
Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 24 weeks (12 weeks post-final laser treatment)
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 532 nm KTP Laser Treatment | Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. | 69 percent of participants |
Secondary
Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Time frame: 24 weeks (12 weeks post-final laser treatment)
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 532 nm KTP Laser Treatment | Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject. | 75 percent of participants |