- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368900
Reducing Wrinkles Around the Eyes Using the Ulthera® System
Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Hunt Valley, Maryland, United States, 21030
- MD Laser Skin & Vein Institute
-
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Tennessee
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Nashville, Tennessee, United States, 37203
- The Nashville Centre for Laser and Facial Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ulthera System Treatment
Ulthera treatment to the upper face.
|
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Time Frame: 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.
|
90 days post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
Time Frame: 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:
"Any Improvement" includes subjects assessed in categories 1-3. |
60 days post-treatment
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
Time Frame: 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:
"Any Improvement" includes subjects assessed in categories 1-3. |
90 days post-treatment
|
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
Time Frame: 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:
"Any Improvement" includes subjects assessed in categories 1-3. |
180 days post-treatment
|
Patient Satisfaction Questionnaire 90 Days Post-treatment
Time Frame: 90 days post-treatment
|
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
|
90 days post-treatment
|
Patient Satisfaction Questionnaire at 180 Days Post-treatment
Time Frame: 180 days post-treatment
|
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
|
180 days post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Assessment of Pain
Time Frame: Average pain scores reported during study treatment
|
Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.
|
Average pain scores reported during study treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Weiss, M.D., MD Laser Skin & Vein Institute
- Principal Investigator: Brian Biesman, M.D., The Nashville Centre for Laser and Facial Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ULT-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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