Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Ulthera

Status: Completed

Conditions: Skin Laxity

Treatments: Device: Ulthera System Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01713998

ULT-300

Details and patient eligibility

About

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. 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 trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Enrollment: 47 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 face and neck

Exclusion criteria

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face or neck.
• Excessive skin laxity on the face or neck.
• Significant scarring in areas to be treated.
• Open wounds or lesions in the area to be treated.
• Severe or cystic acne on the area to be treated.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 3 patient groups

Group A

Active Comparator group

Description:

Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.

Treatment:

Device: Ulthera System Treatment

Group B

Active Comparator group

Description:

Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.

Treatment:

Device: Ulthera System Treatment

Group C

Active Comparator group

Description:

Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.

Treatment:

Device: Ulthera System Treatment