Feasibility Study: Lifting and Tightening Neck Skin in Patients

Completed · Not applicable

Conditions studied: Skin Laxity

In brief

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.

Key facts

Study ID

NCT01708928

Run by

Ulthera, Inc

People needed

30

Starts

2010-08-01

Expected to finish

2012-08-01

Last updated by the study team

2017-11-24

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, aged 30 to 65 years
• Subject in good health
• Body Mass index of less than 30
• Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
• Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
• Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
• 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
• Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control

You may not qualify if…

• Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
• Has an active systemic or local skin disease that may alter wound healing
• Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
• Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy

Where it is running

• DeNova Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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