Mild to Moderate Skin Laxity on Cheek Clinical Trial
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
| Verified date | January 2014 |
| Source | Merz North America, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | April 2011 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 35 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Male or female, aged 35 to 60 years - Subject in good health - Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity Exclusion Criteria: - Pregnant or lactating - Has an active systemic or local skin disease that may alter wound healing - Severe solar elastosis - Excessive subcutaneous fat on the cheeks - Excessive skin laxity on the lower face and neck - Has significant scarring in areas to be treated - Has significant open facial wounds or lesions - Has severe or cystic acne on the face |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ulthera, Inc | University of Texas Southwestern Medical Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Subject Assessment of Pain | Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region. | During Ulthera study treatment | |
| Primary | Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. | The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit. | 90D | |
| Secondary | Change in Submental and Neck Skin Laxity by Quantitative Analysis | The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis. | 90D | |
| Secondary | Patient Satisfaction Questionnaire | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated. | 90D |