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Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Primary Purpose

Facial Skin Laxity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System treatment
Sponsored by
Ulthera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Skin Laxity

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.
  • Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
  • Fitzpatrick skin phototypes of 3 through 6.
  • Provide written informed consent and HIPAA authorization

Exclusion Criteria:

  • Pregnant or lactating.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat on the cheek.
  • 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.

Sites / Locations

  • Harris Aesthetics, LLC
  • Dermatology, Cosmetic & Laser Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ulthera® System treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in Overall Lifting and Tightening of Treated Tissue
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos

Secondary Outcome Measures

Global Aesthetic Improvement at 90 Days Post-treatment
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Global Aesthetic Improvement at 180 Days Post-treatment
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.

Full Information

First Posted
June 6, 2011
Last Updated
November 16, 2017
Sponsor
Ulthera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01368965
Brief Title
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Official Title
Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (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
No

5. Study Description

Brief Summary
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
Detailed Description
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulthera® System treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ulthera® System treatment
Intervention Description
Ulthera® System treatment delivering focused ultrasound energy
Primary Outcome Measure Information:
Title
Change in Overall Lifting and Tightening of Treated Tissue
Description
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
Time Frame
90 days post treatment
Secondary Outcome Measure Information:
Title
Global Aesthetic Improvement at 90 Days Post-treatment
Description
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Time Frame
90 Days post-treatment
Title
Global Aesthetic Improvement at 180 Days Post-treatment
Description
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Time Frame
180 days post-treatment
Title
Patient Satisfaction Questionnaire
Description
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Time Frame
90 Days post-treatment
Title
Patient Satisfaction Questionnaire
Description
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Time Frame
180 days post-treatment
Other Pre-specified Outcome Measures:
Title
Subject Assessment of Pain
Description
Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.
Time Frame
During Ulthera treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, aged 30 to 65 years. Subject in good health. Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity. Fitzpatrick skin phototypes of 3 through 6. Provide written informed consent and HIPAA authorization Exclusion Criteria: Pregnant or lactating. Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat on the cheek. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hema Sundaram, M.D.
Organizational Affiliation
Dermatology, Cosmetic & Laser Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monte O Harris, M.D.
Organizational Affiliation
Harris Aesthetics, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harris Aesthetics, LLC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Dermatology, Cosmetic & Laser Surgery
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26313402
Citation
Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.
Results Reference
derived

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Lifting and Tightening of the Face in Subjects With Skin of Darker Color

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