N/A
Completed N=48
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Skin Laxity · Wrinkles
Source: ClinicalTrials.gov NCT01519934 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Improvement in Overall Lifting and Tightening of the Skin — 67 percentage of participants
Summary
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Overall Lifting and Tightening of the Skin |
67 | — |
| SECONDARY Overall Aesthetic Improvement |
78; 78 | — |
| SECONDARY Subject Perception of Age |
60 | — |
| SECONDARY Patient Satisfaction |
60 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age 25-85 years.
- Subject in good health.
- Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
- Absence of physical or psychological conditions unacceptable to the investigator.
Exclusion Criteria
- Presence of an active systemic or local skin disease that may affect wound healing.
- Significant scarring in areas treated.
- Open wounds or lesions in the areas treated.
- Severe or cystic acne on the areas treated.
- Inability to understand the protocol or to give informed consent.
Data sourced from ClinicalTrials.gov (NCT01519934). 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.