Ultherapy for the Treatment of Spider Veins on the Legs

NCT02286804 | Completed

• 1 other identifier: ULT-301
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Telangiectasia; Spider Veins

Outcome Measures

Primary Outcomes (1)

• Improvement of leg telangiectasia

  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)

  60 days post-treatment

Secondary Outcomes (6)

• Clinician assessment of overall aesthetic improvement

  30 days post-treatment

• Clinician assessment of overall aesthetic improvement

  60 days post-treatment

• Subject assessment of overall aesthetic improvement

  30 days post-treatment

• Subject assessment of overall aesthetic improvement

  60 days post-treatment

• Patient Satisfaction

  30 days post-treatment

Study Arms (1)

Ultherapy treatment

EXPERIMENTAL

Subjects receiving Ultherapy treatment to up to 4 spider veins

Device: Ultherapy

Interventions

Ultherapy DEVICE

Micro-focused ultrasound energy delivered below the surface of the skin

Also known as: Ulthera System

Ultherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. Washout period for limited acute NSAID use, i.e., a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure

You may not qualify if:

• 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 30.
• History of chronic drug or alcohol abuse.
• History of diabetes.
• History of keloid scarring, hypertrophic scarring or abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of thromboembolic disease, such as deep vein thrombosis (DVT).
• History of autoimmune disease.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Ulthera, Inc.

Mesa, Arizona, 85204, United States

Location

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lisa Misell, PhD

  Ulthera, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Improvement of leg telangiectasia was determined by a masked, qualitative assessment of 2D photographs compared to baseline.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 19, 2017

Record last verified: 2015-05

Locations

US (1)