A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Ulthera

Status: Completed

Conditions: Wrinkles; Skin Laxity

Study type: Observational

Funder types: Industry

Identifiers

NCT01519934

ULT-120

Details and patient eligibility

About

Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Full description

This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Enrollment: 48 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, age 25-85 years.
• Subject in good health.
• Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
• Absence of physical or psychological conditions unacceptable to the investigator.

Exclusion criteria

• Presence of an active systemic or local skin disease that may affect wound healing.
• Significant scarring in areas treated.
• Open wounds or lesions in the areas treated.
• Severe or cystic acne on the areas treated.
• Inability to understand the protocol or to give informed consent.

Trial design

48 participants in 1 patient group

Ulthera-treated subjects

Description:

All enrolled subjects will have received an Ulthera treatment prior to enrollment.