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TelangiectasiaNCT02286804

Ultherapy for the Treatment of Spider Veins on the Legs

A study testing Ultherapy in people with Telangiectasia and Spider Veins, run by Ulthera, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Telangiectasia, Spider Veins
What is being tested?
Ultherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Oct 2014to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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

Who cannot join

  • 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.
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  • 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.
  • Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
  • Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  • Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
  • Concurrent enrollment in any study involving the use of investigational devices or drugs.
  • Current smoker or history of smoking in the last five years.
  • History of using the following prescription medications:
  • Accutane or other systemic retinoids within the past six months;
  • Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
  • Chronic use of non-steroidal anti-inflammatories (naproxen, ibuprofen, etc.) within the past 4 weeks;
  • Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ulthera, Inc.

    Mesa, Arizona, 85204

Other trials in United States

About this study

Official title: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Leg Telangiectasia

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.

Read the 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.

Being tested
Ultherapy
Medical subject headings
Telangiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltherapyDevice

    Also called Ulthera System

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

Study groups in NCT02286804
Study groupRoleWhat they receive
Ultherapy treatmentExperimentalSubjects receiving Ultherapy treatment to up to 4 spider veins
Receives: Device: Ultherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 60 days post-treatment

Secondary outcomes (6)

  1. Clinician assessment of overall aesthetic improvement

    Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:

    1. Very Much Improved: Optimal cosmetic result in this subject.
    2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
    3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
    4. No Change: The appearance is essentially the same as the original condition.
    5. Worse: The appearance is worse than the original condition.

    Measured: 30 days post-treatment

  2. Clinician assessment of overall aesthetic improvement

    Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:

    1. Very Much Improved: Optimal cosmetic result in this subject.
    2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
    3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
    4. No Change: The appearance is essentially the same as the original condition.
    5. Worse: The appearance is worse than the original condition.

    Measured: 60 days post-treatment

  3. Subject assessment of overall aesthetic improvement

    Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:

    1. Very Much Improved: Optimal cosmetic result in this subject.
    2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
    3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
    4. No Change: The appearance is essentially the same as the original condition.
    5. Worse: The appearance is worse than the original condition.

    Measured: 30 days post-treatment

  4. Subject assessment of overall aesthetic improvement

    Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:

    1. Very Much Improved: Optimal cosmetic result in this subject.
    2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
    3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
    4. No Change: The appearance is essentially the same as the original condition.
    5. Worse: The appearance is worse than the original condition.

    Measured: 60 days post-treatment

  5. Patient Satisfaction

    Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale:

    • Very Satisfied
    • Satisfied
    • Slightly Satisfied
    • Neither Satisfied or Dissatisfied
    • Dissatisfied

    Measured: 30 days post-treatment

  6. Patient Satisfaction

    Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale:

    • Very Satisfied
    • Satisfied
    • Slightly Satisfied
    • Neither Satisfied or Dissatisfied
    • Dissatisfied

    Measured: 60 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionApr 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286804
Sponsor's protocol ID
ULT-301
Status last verified
May 2015
First submitted
5 Nov 2014
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultherapy in people with Telangiectasia and Spider Veins, run by Ulthera, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of leg telangiectasia (time frame: 60 days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02286804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

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