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Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

Ulthera logo

Ulthera

Status

Completed

Conditions

Skin Laxity

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01519206
ULT-124

Details and patient eligibility

About

The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Full description

All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Enrollment

32 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
  • Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup 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 on the cheeks
  • Excessive skin laxity on the lower 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, a pacemaker, or cochlear implants

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Ultherapy treatment
Experimental group
Description:
Ulthera System Treatment
Treatment:
Device: Ulthera System Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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