Feasibility Study: Lifting and Tightening Neck Skin in Patients

Ulthera

Status

Completed

Conditions

Skin Laxity

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01708928

ULT-107

Details and patient eligibility

About

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.

Full description

This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.

Enrollment

30 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
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

Exclusion criteria

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