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

June 6, 2011
February 10, 2014
March 2011
October 2011   (final data collection date for primary outcome measure)
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
Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment compared to baseline ] [ Designated as safety issue: No ]
Improvement in overall lifting and tightening of skin as determined by masked qualitative assessment of 90 day post treatment photographs compared to baseline.
Complete list of historical versions of study NCT01368965 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
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.
Not Provided
 
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Facial Skin Laxity
Device: Ulthera® System treatment
Ulthera® System treatment delivering focused ultrasound energy
Experimental: Ulthera® System treatment
Intervention: Device: Ulthera® System treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
August 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01368965
ULT-112
No
Ulthera, Inc
Ulthera, Inc
Not Provided
Principal Investigator: Hema Sundaram, M.D. Dermatology, Cosmetic & Laser Surgery
Principal Investigator: Monte O Harris, M.D. Harris Aesthetics, LLC
Ulthera, Inc
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP