Evaluation of the Ulthera® System for Treatment of the Face and Neck
|ClinicalTrials.gov Identifier: NCT01713907|
Recruitment Status : Terminated (Inadequate study staff to appropriately manage trial.)
First Posted : October 25, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Wrinkles Rhytids Skin Laxity||Device: Ulthera® Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||January 2012|
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.
- Improvement in facial wrinkles and lifting and tightening of skin [ Time Frame: 90 days post-treatment ]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 ]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 ]Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713907
|United States, Maryland|
|Dermatology, Cosmetic & Laser Surgery|
|Rockville, Maryland, United States, 20852|
|Principal Investigator:||Hema Sundaram, MD||Dermatology, Cosmetic & Laser Surgery|