Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System



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:January 2012

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Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

This prospective, multi-center, single treatment clinical trial evaluates the clinical
outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and
neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner
below the surface of the skin.

The primary objective of this clinical trial is to demonstrate the effectiveness of the
Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Inclusion Criteria:

- Male or female, aged 30 to 65 years.

- Subject in good health.

- Skin laxity in the lower face and neck.

- Willingness and ability to comply with protocol requirements and return for follow-up
visits.

- Provides 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 in the face and lower neck.

- Excessive skin laxity on the 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.
We found this trial at
2
sites
4500 Biscayne Boulevard
Miami Beach, Florida 33140
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Miami Beach, FL
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Edina, Minnesota 55424
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Edina, MN
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