Evaluation of the Ulthera® System for Treatment of the Face and Neck
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|