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

Skin Laxity Clinical Trial

Official title:

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01713907
• Other study ID #: ULT-109
• Status: Terminated
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 22, 2017
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Rhytids
• Skin Laxity
• Wrinkles

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology, Cosmetic & Laser Surgery	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in facial wrinkles and lifting and tightening of skin	Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline	90 days post-treatment
Secondary	Overall aesthetic improvement	Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.	Participants will be followed up to 180 days post-treatment
Secondary	Overall patient satisfaction	Determined based on Patient Satisfaction and Quality of Life questionnaire scores.	90 and 180 day post-treatment