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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01368965
First received: June 6, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Facial Skin Laxity
Device: Ulthera® System treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Change in Overall Lifting and Tightening of Treated Tissue [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Subject Assessment of Pain [ Time Frame: During Ulthera treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 54
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulthera® System treatment Device: Ulthera® System treatment
Ulthera® System treatment delivering focused ultrasound energy

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368965

Locations
United States, Maryland
Harris Aesthetics, LLC
Chevy Chase, Maryland, United States, 20815
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Hema Sundaram, M.D. Dermatology, Cosmetic & Laser Surgery
Principal Investigator: Monte O Harris, M.D. Harris Aesthetics, LLC
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01368965     History of Changes
Other Study ID Numbers: ULT-112
Study First Received: June 6, 2011
Results First Received: February 10, 2014
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014