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This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical anesthetic - L.M.X.4.® cream | Active Comparator | Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment. |
|
| Placebo cream | Placebo Comparator | A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L.M.X.4.® cream | Drug | A lidocaine topical anesthetic cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related pain | The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated. | During treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in skin laxity. | Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs. | 90 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Gitt, MD | North Valley Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Valley Plastic Surgery | Phoenix | Arizona | 85050 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| A placebo cream | Other | Placebo cream containing no anesthetic properties. |
|
| Ulthera System Treatment | Device | Focused ultrasound energy delivered below the surface of the skin |
|
|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |