Text Size

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 27, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • 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.


Enrollment: 55
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
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
Last Updated: February 27, 2013
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 June 17, 2013