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Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients (ULT-302)

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ClinicalTrials.gov Identifier: NCT03351335
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Ulthera, Inc
Information provided by (Responsible Party):
Merz North America, Inc.

Brief Summary:
To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

Condition or disease Intervention/treatment Phase
Mild to Moderate Skin Laxity Under the Chin Mild to Moderate Skin Laxity on Neck Device: Microfocused ultrasound with visualization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultherapy®, energy level 3
Group 1: Subjects will receive Ultherapy® treatment at energy level 3 (EL3).
Device: Microfocused ultrasound with visualization
All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
Other Name: Ultherapy®

Experimental: Ultherapy®, energy level 4
Group 2: Subjects will receive Ultherapy® treatment at energy level 4 (EL4).
Device: Microfocused ultrasound with visualization
All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
Other Name: Ultherapy®

Experimental: Ultherapy®, energy level 2
Group 3: Subjects will receive Ultherapy® treatment at energy level 2 (EL2).
Device: Microfocused ultrasound with visualization
All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
Other Name: Ultherapy®




Primary Outcome Measures :
  1. Improvement in overall lifting of submental (under the chin) and neck tissue [ Time Frame: From baseline to day 90 ]
    Lifiting is determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3D digital imaging System. Improvement is defined as a response rate > 60% whereby a responder is defined as a subject showing a submental lift of ≥13mm2.


Secondary Outcome Measures :
  1. Improvement in overall lifting and tightening on Physician Global Aesthetic Improvement Scale (PGAIS) [ Time Frame: From baseline to day 90 ]

    The PGAIS is a 5-point scale that rates global aesthetic improvement from the pretreatment appearance. The ratings are much worse, worse, no change, improved, much improved, and very much improved.

    Improvement in overall lifting and tightening of skin is defined by the subject response rate (improved, much improved or very much improved) as determined by live assessment compared to baseline photograph.


  2. Improvement in overall lifting and tightening on Subject Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: From baseline to day 90 ]

    The SGAIS is a 5-point scale that rates global aesthetic improvement from the pretreatment appearance. The ratings are much worse, worse, no change, improved, much improved, and very much improved.

    Improvement in overall lifting and tightening of skin is defined by the subject response rate (improved, much improved or very much improved) as determined by live assessment compared to baseline photograph.


  3. Comparison of improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. [ Time Frame: From baseline to day 90 ]
    The blinded Assessor will be with identical sets of photos to be assessed: pre-treatment and Day 90 post-treatment photos, pre and post treatment, will not be marked. Either "no improvement" versus "improvement" will be assessed.

  4. Subject satisfaction at 90 days post-treatment [ Time Frame: From baseline to day 90 ]
    Subject satisfaction will be assessed by a 7-point scale (extremely dissatisfied, dissatisfied, slightly dissatisfied, neither satisfied or dissatisfied, slightly satisfied, satisfied, extremely satisfied)

  5. Subject reported improvement at 90 days post-treatment [ Time Frame: From baseline to day 90 ]
    Subject reported improvement will be assessed by a 5-point scale (worse, no change, a little improved, improved, much improved).



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Both parents of full Chinese decent.
  2. Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
  3. Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
  4. Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
  5. 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:

    1. Postmenopausal with last menstrual bleeding at least 12 months prior to study; and
    2. Without a uterus and/or both ovaries.
  6. Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.
  7. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
  8. Willingness and ability to provide written informed consent prior to performance of any study-related procedure.

Exclusion Criteria:

  1. Presence of an active systemic or local skin disease that may affect wound healing.
  2. Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
  3. Severe solar elastosis.
  4. Excessive subcutaneous fat in the area(s) to be treated.
  5. Excessive skin laxity on the area(s) to be treated.
  6. Significant scarring in the area(s) to be treated that would interfere with assessing results.
  7. Open wounds or lesions in the area(s) to be treated.
  8. Severe or cystic acne on the area(s) to be treated.
  9. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
  10. Inability to understand the protocol or to give informed consent.
  11. Allergy or sensitivity to pre-treatment medication (ibuprofen).
  12. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
  13. Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
  14. BMI greater than or equal to 30.
  15. History of chronic drug or alcohol abuse.
  16. More than 2-3 doses of any NSAID in any 2-week period prior to and throughout study.
  17. History of autoimmune disease.
  18. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
  19. Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
  20. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
  21. Concurrent enrollment or enrollment in any study involving the use of investigational devices or drugs within the past three months.
  22. Current smoker as defined by

    1. Having smoked one or more cigarettes per day on a daily basis within the past year; or
    2. Smoke cessation within the past 6 months.
  23. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
  24. History of the following cosmetic treatments in the area(s) to be treated:

    1. Skin tightening procedure within the past year;
    2. Injectable filler of any type within the past: i) 9 months for Hyaluronic acid fillers (e.g. Restylane); ii) 24 months for Ca Hydroxyapatite fillers (e.g. Radiesse); iii) 12 months for Long-lasting Hyaluronic acid (Juvéderm Voluma); iv) 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra); v) Ever for permanent fillers (e.g. Silicone, Artecoll)
    3. Neurotoxins within the past three months;
    4. Ablative resurfacing laser treatment;
    5. Nonablative, rejuvenative laser or light treatment within the past six months;
    6. Surgical dermabrasion or deep facial peels;
    7. Facelifts within the past year; or
    8. Any history of contour threads.
  25. History (in the prior year) or current use of the following prescription medications:

    1. Accutane or other systemic retinoids within the past six months;
    2. Topical Retinoids within the past two weeks;
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
    4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351335


Locations
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United States, California
Merz Investigational Site # 0010411
Los Gatos, California, United States, 95032
Merz Investigational Site # 0010321
San Diego, California, United States, 92121
United States, Texas
Merz Investigational Site # 0010410
Austin, Texas, United States, 78745
Sponsors and Collaborators
Merz North America, Inc.
Ulthera, Inc
Investigators
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Study Director: Peter Kreymerman, MD, FA Merz North America

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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT03351335     History of Changes
Other Study ID Numbers: M960001052
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases