Reducing Wrinkles Around the Eyes Using the Ulthera® System
- Conditions
- Periorbital Wrinkles
- Interventions
- Device: Ulthera® System treatment
- Registration Number
- NCT01368900
- Lead Sponsor
- Ulthera, Inc
- Brief 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.
- Detailed Description
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ulthera System Treatment Ulthera® System treatment Ulthera treatment to the upper face.
- Primary Outcome Measures
Name Time Method Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes 90 days post-treatment Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
- Secondary Outcome Measures
Name Time Method Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment 90 days post-treatment At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment 60 days post-treatment At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.Patient Satisfaction Questionnaire at 180 Days Post-treatment 180 days post-treatment Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Patient Satisfaction Questionnaire 90 Days Post-treatment 90 days post-treatment Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment 180 days post-treatment At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.
Trial Locations
- Locations (2)
MD Laser Skin & Vein Institute
🇺🇸Hunt Valley, Maryland, United States
The Nashville Centre for Laser and Facial Surgery
🇺🇸Nashville, Tennessee, United States