Lifting and Tightening of the Face in Subjects With Skin of Darker Color
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 12/15/2017 |
| Start Date: | March 2011 |
| End Date: | August 2012 |
Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6
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.
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.
The primary objective of this clinical trial is to demonstrate the effectiveness of the
Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of
facial tissue and jawline definition improvement.
Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of
facial tissue and jawline definition improvement.
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.
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