Feasibility Study: Ulthera System for the Treatment of Rosacea

Exclusion Criteria

• •Presence of an active systemic disease that may affect wound healing.
• •Prominent telangiectases in the area(s) to be treated.
• •History of post-inflammatory hyperpigmentation.
• •Papulopustular or Phymatous Rosacea.
• •Severe solar elastosis.
• •Significant scarring in 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.
• •Presence of a metal stent or implant in the area(s) to be treated.
• •Inability to understand the protocol or to give informed consent.
• •Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within six 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.
• •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 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:
• •* 12 months for Hyaluronic acid fillers (e.g.,Restylane)
• •* 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse)
• •* 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra)
• •* Ever for permanent fillers (e.g., Silicone, ArteFill)
• •3. Neurotoxins within the past three 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
• •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 informed consent.