Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

Ulthera

Status: Completed

Conditions: Wrinkles; Skin Laxity

Treatments: Device: Ulthera System Treatment; Device: Thermage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01713985

ULT-135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group A

Active Comparator group

Description:

Ulthera System Treatment Right, Thermage Left

Treatment:

Device: Thermage

Device: Ulthera System Treatment

Group B

Active Comparator group

Description:

Ulthera System Treatment Left, Thermage Right

Treatment:

Device: Thermage

Device: Ulthera System Treatment