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

NCT03351335 | Completed Results FDA Device

• 1 other identifier: M960001052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Mild to Moderate Skin Laxity Under the Chin; Mild to Moderate Skin Laxity on Neck

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment

  Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.

  Baseline and Day 90

Secondary Outcomes (4)

• 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

  Day 90

• 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

  Day 90

• 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

  Day 90

• Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment

  Day 90

Study Arms (3)

Ultherapy®, energy level 3

EXPERIMENTAL

Group 1: Subjects will receive Ultherapy® treatment at energy level 3 (EL3).

Device: Microfocused ultrasound with visualization

Ultherapy®, energy level 4

EXPERIMENTAL

Group 2: Subjects will receive Ultherapy® treatment at energy level 4 (EL4).

Device: Microfocused ultrasound with visualization

Ultherapy®, energy level 2

EXPERIMENTAL

Group 3: Subjects will receive Ultherapy® treatment at energy level 2 (EL2).

Device: Microfocused ultrasound with visualization

Interventions

Microfocused ultrasound with visualization DEVICE

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.

Also known as: Ultherapy®

Ultherapy®, energy level 2; Ultherapy®, energy level 3; Ultherapy®, energy level 4

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both parents of full Chinese decent.
• Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
• Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
• 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.
• 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 with last menstrual bleeding at least 12 months prior to study; and
• Without a uterus and/or both ovaries.
• Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.
• 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 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 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.
• Severe solar elastosis.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity on the area(s) to be treated.
• Significant scarring in the area(s) to be treated that would interfere with assessing results.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
• Inability to understand the protocol or to give informed consent.
• Allergy or sensitivity to pre-treatment medication (ibuprofen).
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• BMI greater than or equal to 30.
• History of chronic drug or alcohol abuse.

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Ulthera, Inc: collaborator

Study Sites (7)

Merz Investigational Site # 0010411

Los Gatos, California, 95032, United States

Location

Merz Investigational Site # 0010321

San Diego, California, 92121, United States

Location

Merz Investigational Site # 0010358

Vista, California, 92083, United States

Location

Merz Investigational Site # 0010410

Austin, Texas, 78745, United States

Location

Merz Investigational Site # 0010422

Bellaire, Texas, 77401, United States

Location

Merz Investigational Site # 0010423

Houston, Texas, 77056, United States

Location

Merz Investigational Site # 0010125

Plano, Texas, 75093, United States

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Peter Kreymerman, MD, FA

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: August 10, 2017
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2018-08

Locations

US (7)