Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments

Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment

This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.

This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.

Inclusion Criteria:

• Male or female, aged 30 to 65 years
• Subject in good health
• Skin laxity on the upper and lower face and neck
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period

Exclusion Criteria:

• Known sensitivity to ibuprofen, acetaminophen, or opiates
• Presence of an active systemic or local skin disease that may affect wound healing
• Severe solar elastosis
• Excessive subcutaneous fat in the face and neck
• Excessive skin laxity on the face and neck
• Significant scarring in areas to be treated
• Significant open facial wounds or lesions
• Severe or cystic acne on the face
• Presence of a metal stent or implant in the facial area to be treated