N/A
N=52
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Facial Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT01368965 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Change in Overall Lifting and Tightening of Treated Tissue
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera® System treatment (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Ulthera, Inc
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Lifting and Tightening of Treated Tissue |
— | — |
| SECONDARY Global Aesthetic Improvement at 90 Days Post-treatment |
85.4; 79.2 | — |
| SECONDARY Global Aesthetic Improvement at 180 Days Post-treatment |
54.0; 77.0 | — |
| SECONDARY Patient Satisfaction Questionnaire |
72.5 | — |
| SECONDARY Patient Satisfaction Questionnaire |
72.5 | — |
Summary
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 30 to 65 years.
- Subject in good health.
- Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
- Fitzpatrick skin phototypes of 3 through 6.
- Provide written informed consent and HIPAA authorization
Exclusion Criteria
- Pregnant or lactating.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheek.
- Excessive skin laxity on the lower face and neck.
- Significant scarring in areas to be treated.
- Significant open facial wounds or lesions.
- Severe or cystic acne on the face.
- Presence of a metal stent or implant in the facial area to be treated.
Data sourced from ClinicalTrials.gov (NCT01368965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.