N/A
Completed N=52
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Facial Skin Laxity
Source: ClinicalTrials.gov NCT01368965 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Change in Overall Lifting and Tightening of Treated Tissue
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.
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 | — |
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. Informational only — not medical advice.