Evaluation of the Ulthera® System for Treatment of the Face and Neck

Not Applicable

Terminated

• Conditions: Rhytids; Skin Laxity; Wrinkles

• Registration Number: NCT01713907
• Lead Sponsor: Ulthera, Inc

Brief Summary

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2013-02
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
• Mild to moderate rhytids in the periorbital or perioral region.
• Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
• Mild to moderate vertical perioral lines
• Mild to moderate marionette lines.
• Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat on the cheek.
• Excessive skin laxity on the lower face and neck.
• Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
• Excessive hooding with or without redundant skin in the areas to be treated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in facial wrinkles and lifting and tightening of skin	90 days post-treatment	Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline

Secondary Outcome Measures

Name	Time	Method
Overall patient satisfaction	90 and 180 day post-treatment	Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Overall aesthetic improvement	Participants will be followed up to 180 days post-treatment	Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.

Trial Locations

Locations (1)

Dermatology, Cosmetic & Laser Surgery; 🇺🇸 Rockville, Maryland, United States