Not provided
Not provided
Not provided
Not provided
Not provided
Inadequate study staff to appropriately manage trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera® treatment | Experimental | All enrolled subjects will receive one full face and neck Ulthera® treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® Treatment | Device | Focused ultrasound energy delivered below the surface of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in facial wrinkles and lifting and tightening of skin | Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall aesthetic improvement | Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline. | Participants will be followed up to 180 days post-treatment |
| Overall patient satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hema Sundaram, MD | Dermatology, Cosmetic & Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology, Cosmetic & Laser Surgery | Rockville | Maryland | 20852 | United States |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determined based on Patient Satisfaction and Quality of Life questionnaire scores. |
| 90 and 180 day post-treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |