Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

Ulthera

Status: Completed

Conditions: Facial and Neck Skin Laxity

Treatments: Device: Ulthera® System treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368874

ULT-110

Details and patient eligibility

About

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

Full description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Enrollment: 71 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Skin laxity in the lower face and neck.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Provides written informed consent and HIPAA authorization.

Exclusion criteria

• Pregnant or lactating.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face and lower neck.
• Excessive skin laxity on the face and neck.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 3 patient groups

Group A

Active Comparator group

Description:

Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.

Treatment:

Device: Ulthera® System treatment

Group B

Active Comparator group

Description:

Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.

Treatment:

Device: Ulthera® System treatment

Group C

Active Comparator group

Description:

Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.

Treatment:

Device: Ulthera® System treatment