Clinical trial NCT01713907: Evaluation of the Ulthera® System for Treatment of the Face and Neck
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrinkles
Rhytids
Skin Laxity
Keywords: Ultherapy™ treatment
Ulthera® System
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 15
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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in facial wrinkles and lifting and tightening of skin
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall aesthetic improvement
timeFrame: Participants will be followed up to 180 days post-treatment
measure: Overall patient satisfaction
timeFrame: 90 and 180 day post-treatment
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Dermatology, Cosmetic & Laser Surgery
state: Maryland
Study officials:
affiliation: Dermatology, Cosmetic & Laser Surgery
name: Hema Sundaram, MD
role: PRINCIPAL_INVESTIGATOR
References: