Peri-oral Wrinkles, Peri-orbital Wrinkles
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)
Brief summary
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.
Interventions
Focused ultrasound energy delivered below the surface of the skin
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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: 1. Skin tightening procedure within the past year; 2. Injectable fillers of any type within the past 12 or 24 months, depending on type; 3. Neurotoxins within the past six months; 4. Ablative resurfacing laser treatment; 5. Nonablative, rejuvenative laser or light treatment within the past six months; 6. Surgical dermabrasion or deep facial peels; 7. Facelift, blepharoplasty, or browlift within the past 2 years; or 8. Any history of contour threads. * History of using the following prescription medications: 1. Accutane or other systemic retinoids within the past six months; 2. Topical Retinoids within the past four weeks; 3. Antiplatelet agents/Anticoagulants; 4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2. | Participants will be followed to 90 days post-treatment #2 | Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2. | Participants will be followed to 180 days post-treatment #2 | Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 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. | Participants will be followed to 90 days post-treatment #2 | Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 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. | Participants will be followed to 180 days post-treatment #2 | Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 180 days post-treatment #2. |
| Overall Aesthetic Improvement | Participants will be followed to 90 days post-treatment #2 | Overall aesthetic improvement at 90 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS). |
| Subject Satisfaction | Participants will be followed to 90 days post-treatment #2 | Subject satisfaction will be measured at using a Patient Satisfaction Questionnaire. |
Countries
United States
Outcome results
None listed