N/A
Completed N=47
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
Skin Laxity
Source: ClinicalTrials.gov NCT01713998 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Subjects' Assessment of Pain During Treatment With Lower Energy Settings — 4.5; 6.0; 5.6; 3.7 units on a scale
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.
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 | — |
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. Informational only — not medical advice.