Clinical trial NCT01368965: Lifting and Tightening of the Face in Subjects With Skin of Darker Color
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Overall Lifting and Tightening of Treated Tissue
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Global Aesthetic Improvement at 90 Days Post-treatment
timeFrame: 90 Days post-treatment
measure: Global Aesthetic Improvement at 180 Days Post-treatment
timeFrame: 180 days post-treatment
measure: Patient Satisfaction Questionnaire
timeFrame: 90 Days post-treatment
measure: Patient Satisfaction Questionnaire
timeFrame: 180 days post-treatment
Other outcomes:
measure: Subject Assessment of Pain
timeFrame: During Ulthera treatment
Locations:
city: Chevy Chase
country: United States
facility: Harris Aesthetics, LLC
state: Maryland
city: Rockville
country: United States
facility: Dermatology, Cosmetic & Laser Surgery
state: Maryland
Study officials:
affiliation: Dermatology, Cosmetic & Laser Surgery
name: Hema Sundaram, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Harris Aesthetics, LLC
name: Monte O Harris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.