Evaluation of the Ulthera® System for Treatment of the Face and Neck
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity|
- Improvement in facial wrinkles and lifting and tightening of skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
- Overall aesthetic improvement [ Time Frame: Participants will be followed up to 180 days post-treatment ] [ Designated as safety issue: No ]Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
- Overall patient satisfaction [ Time Frame: 90 and 180 day post-treatment ] [ Designated as safety issue: No ]Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
|Study Start Date:||June 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Ulthera® treatment
All enrolled subjects will receive one full face and neck Ulthera® treatment.
Device: Ulthera® Treatment
Focused ultrasound energy delivered below the surface of the skin.
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713907
|United States, Maryland|
|Dermatology, Cosmetic & Laser Surgery|
|Rockville, Maryland, United States, 20852|
|Principal Investigator:||Hema Sundaram, MD||Dermatology, Cosmetic & Laser Surgery|