N/A
N=47
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT01713998 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Subjects' Assessment of Pain During Treatment With Lower Energy Settings — 4.5; 6.0; 5.6; 3.7 units on a scale
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
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects' Assessment of Pain During Treatment With Lower Energy Settings |
4.5; 6.0; 5.6; 3.7; 3.7; 5.9 | — |
| PRIMARY Overall Improvement in Skin Laxity on the Face and Neck |
6; 6; 6 | — |
| SECONDARY Quantitative Assessment of Brow Lift at 90 Days Post-treatment |
2; 5; 2; 2; 3; 6 | — |
| SECONDARY Subject Assessment of Improvement at 90 Days Post-treatment |
86; 80; 93; 93; 80; 87 | — |
| SECONDARY Subject Assessment of Improvement at 180 Days Post-treatment |
77; 73; 86; 75; 80; 79 | — |
Summary
Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Eligibility Criteria
Inclusion Criteria
- Male or female, age 30 to 65 years.
- Subject in good health.
- Skin laxity on the face and neck
Exclusion Criteria
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face or neck.
- Excessive skin laxity on the face or neck.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
Data sourced from ClinicalTrials.gov (NCT01713998). 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.