Spider Angioma
Conditions
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.
Interventions
DEVICEKTP laser
Dual Wavelength Laser Emitting 532 nm Laser Energy
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment Scale for Improvement of Spider Angioma | Four weeks post laser treatment. | 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 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Laser Treatment |
|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 19.7 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 14 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal
Time frame: Four weeks post laser treatment.
Population: 1 subject was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatment | Physician's Global Assessment Scale for Improvement of Spider Angioma | 4.5 score on a scale | Standard Deviation 0.6 |