N/A
N=64
Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
Facial and Neck Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT01368874 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity — 22; 10; 1; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera® System treatment (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Ulthera, Inc
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity |
22; 10; 1; 11; 12 | — |
| PRIMARY Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP |
22; 10; 1; 11; 12 | — |
| SECONDARY 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. |
78.7; 78.1; 40; 87.5; 79.3; 68.9 | — |
| SECONDARY 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. |
78.7; 78.1; 40; 87.5; 79.3; 68.9 | — |
| SECONDARY 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. |
66.7; 42; 80; 95.8; 93.1; 63.3 | — |
| SECONDARY Patient Satisfaction 90 Days Post-treatment |
82; 81.3; 80; 83.3; 82.8; 65.6 | — |
| SECONDARY Patient Satisfaction Questionnaire 180 Days Post-treatment |
71.7; 67.7; 40; 83.3; 83.3; 55 | — |
| SECONDARY L'Oreal Photographic Scale Baseline |
3.0; 3.0; 3.8; 2.9; 3.1; 3.7 | — |
| SECONDARY L'Oreal Photographic Scale 90 Days Post-treatment |
2.1; 2.6; 2.4; 1.5; 1.6; 2.7 | — |
| SECONDARY L'Oreal Photographic Scale 180 Days Post-treatment |
2.3; 2.7; 2.0; 1.7; 1.7; 2.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01368874). 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.