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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ulthera, Inc
• Treatments: Acetaminophen, hydrocodone drug combination; Ibuprofen

Criteria

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