Ultherapy® for the Treatment of Acne Scars

Exclusion Criteria

• •Presence of an active systemic or local skin disease that may affect wound healing.
• •Severe solar elastosis.
• •Recent history of significant trauma to the face (\<6 months).
• •Significant scarring, other than acne scars in area(s) to be treated.
• •Open wounds or lesions in the area(s) to be treated.
• •Severe or cystic active and clinically significant acne on the area(s) to be treated.
• •Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas.
• •Have a history of systemic granulomatous diseases active or inactive or connective tissue disease.
• •Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
• •Presence of a metal stent or implant in the area(s) to be treated.
• •Inability to understand protocol or give informed consent.
• •Microdermabrasion or glycolic acid peels to the treatment area(s) within four weeks prior to study participation or during the study.
• •History of allergic reaction to Ibuprofen, Acetaminophen, or Lidocaine/Tetracaine.
• •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, or participated within the past 30 days, in any study involving the use of investigational devices or drugs.
• •Current smoker or history of smoking in the last two years.
• •History of the following cosmetic treatments in the areas 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.,Restylane); ii. 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse); iii. 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra); iv. Cultured fibroblast (e.g. LaViv) within the past two years; v. Ever for permanent fillers (e.g., Silicone, ArteFill)
• •3. Neurotoxins within the past three months;
• •4. Ablative resurfacing laser treatment within the past two years;
• •5. Nonablative, rejuvenative laser or light treatment within the past six months;
• •6. Surgical dermabrasion or deep facial peels within the past two years;
• •7. 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, chronic NSAID use);
• •4. Aspirin greater than 82mg/day
• •5. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent or affect their ability to accurately complete QOL and subjective improvement assessments.
• •Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol.