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Feasibility Study: Lifting and Tightening Neck Skin in Patients

Primary Purpose

Skin Laxity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ulthera System Treatment

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

DeNova Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

Subjects who have previous history of submentoplasty and or rhytidectomy

Subjects naïve to submentoplasty and or rhytidectomy

Outcomes

Primary Outcome Measures

Change in submental volume

Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.

Secondary Outcome Measures

Overall improvement of the submental area

Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.

Full Information

NCT ID

NCT01708928

First Posted

October 15, 2012

Last Updated

November 22, 2017

Sponsor

Ulthera, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01708928

Brief Title

Feasibility Study: Lifting and Tightening Neck Skin in Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ulthera, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Laxity

Keywords

Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Subjects who have previous history of submentoplasty and or rhytidectomy

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Subjects naïve to submentoplasty and or rhytidectomy

Intervention Type

Device

Intervention Name(s)

Ulthera System Treatment

Other Intervention Name(s)

Ultherapy™

Intervention Description

Focused ultrasound energy delivered below the surface of the skin

Primary Outcome Measure Information:

Title

Change in submental volume

Description

Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.

Time Frame

90 days post-treatment

Secondary Outcome Measure Information:

Title

Overall improvement of the submental area

Description

Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.

Time Frame

90 days post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Dayan, MD

Organizational Affiliation

DeNova Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

DeNova Research

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study: Lifting and Tightening Neck Skin in Patients

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