N/A
N=4
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
Spider Veins
Bottom Line
View on ClinicalTrials.gov: NCT02754479 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles — 3.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nd:YAG laser (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Cutera Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles |
3.7 | — |
| SECONDARY Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles |
4.3 | — |
Summary
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
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.
Data sourced from ClinicalTrials.gov (NCT02754479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.