Feasibility Study: Lifting and Tightening Neck Skin in Patients

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708928
• Other study ID #: ULT-107
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 22, 2017
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	DeNova Research	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in submental volume	Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.	90 days post-treatment
Secondary	Overall improvement of the submental area	Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.	90 days post-treatment