Skin Laxity Clinical Trial
Official title:
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees
Verified date | June 2013 |
Source | Merz Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female, aged 30 to 65 years. - Subject in good health. - Mild to moderate skin laxity around the knees. - Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. Exclusion Criteria: - Presence of an active systemic or local skin disease that may affect wound healing. - Excessive subcutaneous fat around the knees. - Excessive skin laxity around the knees. |
Country | Name | City | State |
---|---|---|---|
United States | Tennessee Clinical Research Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in overall lifting and tightening of knee skin laxity. | Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale. | 90 and 180 days post-treatment | |
Secondary | Overall improvement in skin laxity. | Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire. | 90 and 180 days post-treatment |
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