Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Skin Laxity Clinical Trial

Official title:

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713998
• Other study ID #: ULT-300
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 10, 2017
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2017
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Description:

This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, age 30 to 65 years.

• Subject in good health.

• Skin laxity on the face and neck

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.

• Severe solar elastosis.

• Excessive subcutaneous fat in the face or neck.

• Excessive skin laxity on the face or neck.

• Significant scarring in areas to be treated.

• Open wounds or lesions in the area to be treated.

• Severe or cystic acne on the area to be treated.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	Ulthera, Inc.	Mesa	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects' Assessment of Pain During Treatment With Lower Energy Settings	Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.; Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.	Participants were assessed for the duration of study treatment, an average of 75 minutes
Primary	Overall Improvement in Skin Laxity on the Face and Neck	A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.	90 days post-treatment
Secondary	Quantitative Assessment of Brow Lift at 90 Days Post-treatment	Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.	90 days post-treatment
Secondary	Subject Assessment of Improvement at 90 Days Post-treatment	Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.	90 days post-treatment
Secondary	Subject Assessment of Improvement at 180 Days Post-treatment	Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.	180 days post-treatment