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 ]

The validated NRS scale will be used to measure average pain scores reported by subject during treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement in skin laxity [ Time Frame: 90 days following treatment ]

Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.


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