Peri-orbital and Peri-oral Wrinkle Reduction Trial

Study Overview
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Brief Summary
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This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Official Title
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Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions

Conditions
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Peri-orbital Wrinkles, Peri-oral Wrinkles

Intervention / Treatment
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* Device: Ulthera® System Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 30 to 75 years. Subject in good health. BMI<25 Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas. Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by the investigator. Understands and accepts the obligation not to undergo any other procedures, including neurotoxin and filler treatments, on the face through the follow-up period. Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment. Willingness and ability to continue with their current daily skin care routine, with the exception of any use of products containing glycolic acid, for the duration of the study. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study. Absence of physical or psychological conditions unacceptable to the investigator. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup). Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. BMI equal to or greater than 25 Severe solar elastosis. Excessive subcutaneous fat in the area(s) to be treated. Mild or severe skin laxity on the area(s) to be treated. Significant scarring in the area(s) to be treated. Open wounds or lesions in the area(s) to be treated. Severe or cystic acne on the area(s) to be treated. Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the treatment area. Inability to understand the protocol or to give informed consent. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study. Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated. History of chronic drug or alcohol abuse. History of autoimmune disease. History of Bell's Palsy or epilepsy. History of diabetes. Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine, para-aminobenzoic acid (PABA). Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. Subjects who anticipate the need for surgery or overnight hospitalization during the study. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability. Concurrent enrollment in any study involving the use of investigational devices or drugs. Current smoker or history of smoking in the last five years. History of the following cosmetic treatments in the area(s) to be treated: Skin tightening procedure within the past year; Injectable fillers of any type within the past 12 or 24 months, depending on type; Neurotoxins within the past six months; Ablative resurfacing laser treatment; Nonablative, rejuvenative laser or light treatment within the past six months; Surgical dermabrasion or deep facial peels; Facelift, blepharoplasty, or browlift within the past 2 years; or Any history of contour threads. History of using the following prescription medications: Accutane or other systemic retinoids within the past six months; Topical Retinoids within the past four weeks; Antiplatelet agents/Anticoagulants; Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulthera® System Treatment<br>Ulthera® System treatment of the peri-orbital and peri-oral regions. | Device: Ulthera® System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2. | Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2. | Participants will be followed to 90 days post-treatment #2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2. | Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 180 days post-treatment #2. | Participants will be followed to 180 days post-treatment #2 | 
| Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2. | Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 90 days post-treatment #2. | Participants will be followed to 90 days post-treatment #2 | 
| Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2. | Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 180 days post-treatment #2. | Participants will be followed to 180 days post-treatment #2 | 
| Overall Aesthetic Improvement | Overall aesthetic improvement at 90 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS). | Participants will be followed to 90 days post-treatment #2 | 
| Overall Aesthetic Improvement | Overall aesthetic improvement at 180 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS). | Participants will be followed to 180 days post-treatment #2 | 
| Subject Satisfaction | Subject satisfaction will be measured at using a Patient Satisfaction Questionnaire. | Participants will be followed to 90 days post-treatment #2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)