Feasibility Study: Ulthera System for the Treatment of Rosacea

This is an interventional treatment trial for Erythematotelangiectatic Rosacea focused on measuring Rosacea, Ulthera System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for the skin Read More

Inclusion Criteria:

• Male or female, aged 18 to 65 years.
• Subject in good health.
• Clinical diagnosis of Erythematotelangiectatic Rosacea.
• 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.

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.