Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
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|ClinicalTrials.gov Identifier: NCT01708252|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity||Device: Ulthera System Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Ulthera treatment group
All subjects will receive an Ulthera System Treatment
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
- Improvement in lower face and neck skin laxity [ Time Frame: 90 days post-treatment ]Efficacy will be assessed using the 90-day images compared to baseline
- Cervicomental angle [ Time Frame: 90 days post-treatment ]Efficacy will be assessed using the 90-day images compared to baseline.
- Overall aesthetic improvement [ Time Frame: 90 days post-treatment ]Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
- Patient satisfaction [ Time Frame: 90 days post-treatment ]Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
- Pain Assessment [ Time Frame: Treatment visit ]Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
- Patient Satisfaction [ Time Frame: 180 days post-treatment ]Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
- Overall aesthetic improvement [ Time Frame: 180 days post-treatment ]Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
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): NCT01708252
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Steven H Dayan, MD, FACS||DeNova Research|