Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Leg Telangiectasia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Telangiectasia
- Sponsor
- Ulthera, Inc
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Improvement of leg telangiectasia
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Up to 30 enrolled subjects will be treated. Enrolled subjects will receive Ultherapy® treatments along each length of the spider vein. Follow-up visits will occur at 30 and 60 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed Description
This study is a prospective, single center, clinical trial to be conducted at one clinical site. Enrolled subjects will receive up to three Ultherapy® treatments at a single depth, 14 days apart, using a 10-1.5mm transducer. Treatment will be provided along each length of the spider vein and up to four veins will be treated per subject Maximum length of each vein treated is 2cm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female, age 18 years or older.
- •Subject in good health.
- •Fitzpatrick Skin Types I-III.
- •Understands and accepts the obligation not to undergo any other elective procedures, i.e., laser and IPL, in the areas to be treated through the follow-up period.
- •Has up to 4 separate spider veins measuring up to 2 cm in length at a depth of approximately 1.0mm.
- •Has lower extremity spider veins ≤1.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- •Postmenopausal for at least 12 months prior to study;
- •Without a uterus and/or both ovaries; or
Exclusion Criteria
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Presence of significant varicosities or perforator veins in the area(s) to be treated.
- •Presence of large torturous varicose veins in the area(s) to be treated.
- •Significant scarring in the area(s) to be treated.
- •Open wounds or lesions in the area(s) to be treated.
- •Active implants or metallic implants in the treatment areas.
- •Presence of underlying metal hardware attached to bone from previous surgeries.
- •Inability to understand the protocol or to give informed consent.
- •BMI equal to or greater than
- •History of chronic drug or alcohol abuse.
Outcomes
Primary Outcomes
Improvement of leg telangiectasia
Time Frame: 60 days post-treatment
Determined by a masked, qualitative assessment of 2D photographs compared to baseline, based on level of clearance/improvement. Level of improvement scale: * 0 = 0% Improvement (None) * 1 = \< 25% Improvement (Mild) * 2 = 26 to 50% Improvement (Moderate) * 3 = 51 to 75% Improvement (Significant) * 4 = 76 to 100% Improvement (Very Significant)
Secondary Outcomes
- Clinician assessment of overall aesthetic improvement(60 days post-treatment)
- Subject assessment of overall aesthetic improvement(60 days post-treatment)
- Patient Satisfaction(60 days post-treatment)