Clinical trial NCT03351335: Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Official title: Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Skin Laxity Under the Chin
Mild to Moderate Skin Laxity on Neck
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ulthera, Inc
First posted: 2017-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
timeFrame: Baseline and Day 90
Secondary outcomes:
measure: Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment
timeFrame: Day 90
measure: Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment
timeFrame: Day 90
measure: Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
timeFrame: Day 90
measure: Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
timeFrame: Day 90
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Merz Investigational Site # 0010411
state: California
city: San Diego
country: United States
facility: Merz Investigational Site # 0010321
state: California
city: Vista
country: United States
facility: Merz Investigational Site # 0010358
state: California
city: Austin
country: United States
facility: Merz Investigational Site # 0010410
state: Texas
city: Bellaire
country: United States
facility: Merz Investigational Site # 0010422
state: Texas
city: Houston
country: United States
facility: Merz Investigational Site # 0010423
state: Texas
city: Plano
country: United States
facility: Merz Investigational Site # 0010125
state: Texas
Study officials:
affiliation: Merz North America, Inc.
name: Peter Kreymerman, MD, FA
role: STUDY_DIRECTOR
References: