Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

NCT03545412 | Completed Results FDA Device

• 1 other identifier: ULT-215
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Facial Skin Laxity

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90

  Lift improvement as measured by quantitative analysis was considered greater than or equal to (\>=) 20.0 square millimeter (mm\^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.

  Baseline, Day 90

• Number of Participants With Lift in Brow Region at Day 90

  Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.

  Baseline, Day 90

Secondary Outcomes (5)

• Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90

  Baseline, Day 90

• Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90

  Baseline, Day 90

• Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90

  Day 90

• Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180

  Baseline, Day 180

• Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180

  Baseline, Day 180

Study Arms (1)

Microfocused ultrasound with visualization

EXPERIMENTAL

Device: Microfocused ultrasound with visualization

Interventions

Microfocused ultrasound with visualization DEVICE

Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Also known as: Ultherapy

Microfocused ultrasound with visualization

Eligibility Criteria

• Age: 39 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign a written consent form
• Willing to have of facial skin laxity and wrinkles assessed by clinician
• Male or female, aged 39 to 65 years.
• Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if:

• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
• Subcutaneous fillers
• Keloid scar
• Patients with anticoagulant treatment plan.
• Children, pregnant women, breastfeeding women.
• 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)

Sponsors & Collaborators

• Ulthera, Inc: lead

Related Publications (1)

• 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.

  PMID: 28945618 RESULT

Results Point of Contact

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

clinicaltrials@merz.de

+49 69 1503 1

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: January 10, 2014
• Primary Completion: May 20, 2014
• Study Completion: August 20, 2014
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share