Clinical trial NCT01368874: Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial and Neck Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
timeFrame: 90 Days post-treatment
measure: Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
timeFrame: 90 Days post-treatment
Secondary outcomes:
measure: Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
timeFrame: 60 days post-treatment
measure: Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
timeFrame: 90 days post-treatment
measure: Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
timeFrame: 180 days post-treatment
measure: Patient Satisfaction 90 Days Post-treatment
timeFrame: 90 Days post-treatment
measure: Patient Satisfaction Questionnaire 180 Days Post-treatment
timeFrame: 180 days post-treatment
measure: L'Oreal Photographic Scale Baseline
timeFrame: Baseline
measure: L'Oreal Photographic Scale 90 Days Post-treatment
timeFrame: 90 Days post-treatment
measure: L'Oreal Photographic Scale 180 Days Post-treatment
timeFrame: 180 Days post-treatment
Other outcomes:
measure: Subjects' Assessment of Pain
timeFrame: During Ulthera treatment
Locations:
city: Miami Beach
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
Study officials:
affiliation: Baumann Cosmetic and Research Institute
name: Leslie Baumann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zel Skin and Laser Specialist
name: Brian Zelickson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: