Clinical trial NCT01713985: Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
Official title: Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Wrinkles
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 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, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity on the area(s) to be treated.
* 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 in the area(s) to be treated.
* Excessive skin laxity on the area(s) to be treated.
* Significant scarring in the area(s) to be treated.
* Open wounds or lesions in the area(s) to be treated.
* Severe or cystic acne on the area(s) to be treated.
* Presence of a metal stent or implant in the area(s) to be treated.
* Inability to understand the protocol or to give informed consent.
* Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
* Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
* BMI equal to or greater than 25.

Primary outcomes:
measure: Number of Participants with Lifting and Tightening of Skin
timeFrame: 180 days post treatment
measure: Number of Participants with Wrinkle Reduction
timeFrame: 180 days post treatment
Secondary outcomes:
measure: Number of Participants with Eyebrow Lift
timeFrame: 90 days post-treatment
measure: Number of Participants with Lower face and Neck Lift
timeFrame: 90 days post-treatment
measure: Number of Participants Reporting Treatment Satisfaction
timeFrame: 180 days post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: FACES+
state: California
Study officials:
affiliation: Faces+
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: