Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment

This is a prospective, randomized, single-blinded, pilot clinical trial to evaluate the use
of the Ulthera® System in combination with the 70W Alma Pixel CO2 laser for efficacious
results in the treatment of abdominal striae rubra and striae alba. Subjects will be
randomized to one of three treatment groups. Study personnel conducting efficacy measures
will be blinded to the assigned treatment groups.

Changes from baseline in overall skin texture and appearance of abdominal striae will be
assessed at study follow-up visits. 2D images, 3D images and patient satisfaction
questionnaires will be obtained.

Inclusion Criteria:

- Male or female, aged 21 to 65 years.

- Subject in good health.

- Fitzpatrick skin classification type 1-5.

- Striae rubra and alba on the abdomen.

- Understands and accepts the obligation not to undergo any other procedures in the
area(s) 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.

- 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 requirements .

- Willingness and ability to provide written informed consent and HIPAA authorization
prior to performance of any study-related procedure.

- Subjects of childbearing potential must have a negative urine pregnancy test result
and must not be lactating at Visit 1 and be willing and able to use an acceptable
method of birth control during the study

Exclusion Criteria:

- Presence of an active systemic or local skin disease that may affect wound healing.

- Current bacterial or viral infection in the area to be treated.

- Severe solar elastosis.

- Significant scarring or burns in area(s) to be treated.

- Prior radiation therapy in the area(s) to be treated.

- Open wounds or lesions in the area(s) to be treated.

- History of keloid or hypertrophic scarring

- History of irregular pigmentation of the skin, Lichens Planus, Vitiligo or Psoriasis
in the treatment area that in the investigators opinion, would put the subject at
unnecessary risk.

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

- Microdermabrasion, or prescription level glycolic acid treatments to the intended
treatment area(s) within two weeks prior to study participation or during the study.

- 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.

- History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty.

- History of prior Massive Weight Loss

- History of using the following prescription medications:

1. Accutane or other systemic retinoids within the past 12 months;

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

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