Clinical Trial: Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment
Brief Summary: This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.
Detailed Summary: 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.
Sponsor: Ulthera, Inc
Current Primary Outcome: Treatment discomfort [ Time Frame: During treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Improvement in skin laxity [ Time Frame: 90 days following treatment ]
Original Secondary Outcome: Same as current
Information By: Ulthera, Inc
Dates:
Date Received: October 15, 2012
Date Started: July 2011
Date Completion:
Last Updated: June 27, 2013
Last Verified: June 2013