CompletedNot Applicable

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

United States71 participantsStarted 2011-03

Plain-language summary

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.

Who can participate

Age range30 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity

Timeframe: 90 Days post-treatment

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP

Timeframe: 90 Days post-treatment

Trial details

NCT IDNCT01368874

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-06-03

View on ClinicalTrials.gov More Facial and Neck Skin Laxity trials