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Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Ulthera System Treatment Right, Thermage Left |
|
| Group B | Active Comparator | Ulthera System Treatment Left, Thermage Right |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera System Treatment | Device | Focused ultrasound energy delivered below the surface of the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Lifting and Tightening of Skin | Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system. | 180 days post treatment |
| Number of Participants with Wrinkle Reduction | Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system | 180 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Eyebrow Lift | Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline. | 90 days post-treatment |
| Number of Participants with Lower face and Neck Lift |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Cohen, MD | Faces+ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FACES+ | San Diego | California | 92121 | 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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| Thermage | Device | Radiofrequency treatment focusing radiofrequency energy |
|
Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
| 90 days post-treatment |
| Number of Participants Reporting Treatment Satisfaction | Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments. | 180 days post-treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |