N/A
N=68
Reducing Wrinkles Around the Eyes Using the Ulthera® System
Periorbital Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01368900 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes — 47; 50 percentage of participants improved
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 Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes |
47; 50 | — |
| SECONDARY Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment |
60.6; 66.7 | — |
| SECONDARY Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment |
59.7; 67.2 | — |
| SECONDARY Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment |
77.0; 68.9 | — |
| SECONDARY Patient Satisfaction Questionnaire 90 Days Post-treatment |
77.6 | — |
| SECONDARY Patient Satisfaction Questionnaire at 180 Days Post-treatment |
72.1 | — |
Summary
The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 30 to 65 years.
- Subject in good health.
- Mild to moderate rhytids in the periorbital region.
- Willingness and ability to comply with protocol requirements and return for follow-up visits.
- Not pregnant.
- Provide written informed consent and HIPAA authorization.
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.
- Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
- Excessive hooding, with or without redundant skin, in the areas to be treated.
- 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 (NCT01368900). 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.