- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02286804
Ultherapy for the Treatment of Spider Veins on the Legs
Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Leg Telangiectasia
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Mesa, Arizona, United States, 85204
- Ulthera, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultherapy treatment
Subjects receiving Ultherapy treatment to up to 4 spider veins
|
Micro-focused ultrasound energy delivered below the surface of the skin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of leg telangiectasia
Time Frame: 60 days post-treatment
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Determined by a masked, qualitative assessment of 2D photographs compared to baseline, based on level of clearance/improvement. Level of improvement scale:
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60 days post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician assessment of overall aesthetic improvement
Time Frame: 30 days post-treatment
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Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:
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30 days post-treatment
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Clinician assessment of overall aesthetic improvement
Time Frame: 60 days post-treatment
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Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:
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60 days post-treatment
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Subject assessment of overall aesthetic improvement
Time Frame: 30 days post-treatment
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Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:
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30 days post-treatment
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Subject assessment of overall aesthetic improvement
Time Frame: 60 days post-treatment
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Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale:
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60 days post-treatment
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Patient Satisfaction
Time Frame: 30 days post-treatment
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Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale:
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30 days post-treatment
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Patient Satisfaction
Time Frame: 60 days post-treatment
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Subjects will rate their satisfaction with the outcome of their treatment based on completion of a patient satisfaction questionnaire using the following scale:
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60 days post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lisa Misell, PhD, Ulthera, Inc
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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