Clinical trial NCT03545412: Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Official title: Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 39
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of the Ulthera® system for facial laxity and sagging skin


Eligibility criteria: Inclusion Criteria:

1. Willing to sign a written consent form
2. Willing to have of facial skin laxity and wrinkles assessed by clinician
3. Male or female, aged 39 to 65 years.
4. Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
5. Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
6. Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
7. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria:

1. Open wounds or lesions in the area(s) to be treated.
2. Severe or cystic acne on the area(s) to be treated.
3. Presence of an active systemic or local skin disease that may affect wound healing.
4. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
5. Subcutaneous fillers
6. Keloid scar
7. Patients with anticoagulant treatment plan.
8. Children, pregnant women, breastfeeding women.
9. Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)

Primary outcomes:
measure: Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
timeFrame: Baseline, Day 90
measure: Number of Participants With Lift in Brow Region at Day 90
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
timeFrame: Baseline, Day 90
measure: Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
timeFrame: Baseline, Day 90
measure: Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
timeFrame: Day 90
measure: Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
timeFrame: Baseline, Day 180
measure: Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
timeFrame: Baseline, Day 180
Other outcomes:
Locations:
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181.