Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Facial Skin Laxity Clinical Trial

Official title:

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368965
• Other study ID #: ULT-112
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: November 16, 2017
• Start date: March 2011
• Est. completion date: August 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

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

Description:

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 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.

• Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.

• Fitzpatrick skin phototypes of 3 through 6.

• Provide written informed consent and HIPAA authorization

Exclusion Criteria:

• Pregnant or lactating.

• 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.

• Significant scarring in areas to be treated.

• Significant open facial wounds or lesions.

• Severe or cystic acne on the face.

• Presence of a metal stent or implant in the facial area to be treated.

Related Conditions & MeSH terms

• Cutis Laxa
• Facial Skin Laxity

Intervention

Device:
• Ulthera® System treatment
Ulthera® System treatment delivering focused ultrasound energy

Locations

Country	Name	City	State
United States	Harris Aesthetics, LLC	Chevy Chase	Maryland
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
Other	Subject Assessment of Pain	Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.	During Ulthera treatment
Primary	Change in Overall Lifting and Tightening of Treated Tissue	The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos	90 days post treatment
Secondary	Global Aesthetic Improvement at 90 Days Post-treatment	At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.	90 Days post-treatment
Secondary	Global Aesthetic Improvement at 180 Days Post-treatment	At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.	180 days post-treatment
Secondary	Patient Satisfaction Questionnaire	Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.	90 Days post-treatment
Secondary	Patient Satisfaction Questionnaire	Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.	180 days post-treatment