Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

This is a prospective, multi-center, split-face, randomized pilot trial to determine the
clinical feasibility of the simulines transducers, i.e., transducers which deliver two lines
of treatment simultaneously (at once), in comparison to the standard transducers which
deliver a single treatment line, by collecting average pain scores in the treated regions, as
well as efficacy and treatment efficiency data. There will be 3 study arms with each arm
having 2 treatment groups. Enrolled subjects will be randomized to one of two study arms, and
one of two treatment groups within each study arm.to determine which side of the face will be
treated with standard transducers and simulines transducers and the energy level for
treatment. Subjects will receive one dual-depth treatment at 4.5mm and 3.0mm depths.

Clinical feasibility will be assessed based on comfort level of standard transducers versus
simulines transducers by comparing average pain scores obtained during study treatment.
Efficacy will be determined based on qualitative masked assessment of post-treatment
photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements.
Patient satisfaction questionnaires will be obtained.

Inclusion Criteria:

- Male or female, age 30 to 65 years.

- Subject in good health.

- Skin laxity on the area(s) to be treated.

- Understands and accepts the obligation not to undergo any other procedures in the
areas to be treated through the follow‐up period.

- 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 (e.g. barrier methods used with a spermicidal
agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study.
Women will not be considered of childbearing potential if one of the following
conditions is documented on the medical history:

1. Postmenopausal for at least 12 months prior to study;

2. Without a uterus and/or both ovaries; or

3. Bilateral tubal ligation at least six months prior to study enrollment.

- Absence of physical or psychological conditions unacceptable to the investigator.

- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID
prior to each study treatment and chronic use during the entire posttreatment study
period. Washout period, if chronic user, for 4 weeks prior to the first treatment.
Washout period for limited acute NSAID use, i.e., a maximum of 2‐3 doses, is required
in the 2 weeks prior to any study treatment visit.

- 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.

- Severe solar elastosis.

- Excessive subcutaneous fat in the area(s) to be treated.

- Excessive 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 implants (e.g., pacemakers or defibrillators), or metallic implants in the
treatment areas (dental implants not included).

- Inability to understand the protocol or to give informed consent.

- Microdermabrasion, or prescription level glycolic acid treatment to the treatment
area(s) within two 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.

- BMI equal to or greater than 25.

- History of chronic drug or alcohol abuse.

- History of autoimmune disease.

- Concurrent 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.

- Current user of any nicotine‐containing products, e.g., e‐cigarettes, Nicorette gum,
nicotine patches, etc.

- History of the following cosmetic treatments in the area(s) to be treated:

1. Skin tightening procedure within the past year;

2. Injectable filler of any type within the past:

i.12 months for Hyaluronic acid fillers (e.g. Rstylane)

ii.12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)

iii. 24 months for Poly‐L‐Lactic acid fillers (e.g. Sculptra)

iv. Ever for permanent fillers (e.g. Silicone, ArteFill)

c. Neurotoxins within the past six months; d. Ablative resurfacing laser treatment; e.
Nonablative, rejuvenative laser or light treatment within the past six months; f. Surgical
dermabrasion or deep facial peels; g. Facelifts, blepharoplasty, or browlift within the
past 18 months; or h. 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 two weeks;

3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);

4. Psychiatric drugs that in the investigators opinion would impair the subject from
understanding the protocol requirements or understanding and signing the informed
consent.