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

Overview

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

Full Title of Study: “Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 2012

Detailed Description

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.

Interventions

  • Drug: Advil
    • One (1) tablet 800 mg Advil one hour prior to treatment.
  • Drug: Lortab
    • One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
  • Device: Ulthera System Treatment
    • Focused ultrasound energy delivered below the surface of the skin

Arms, Groups and Cohorts

  • Active Comparator: Advil with Ultherapy
    • Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
  • Active Comparator: Lortab with Ultherapy
    • Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Treatment discomfort
    • Time Frame: During treatment
    • The validated NRS scale will be used to measure average pain scores reported by subject during treatment.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ulthera, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hema Sundaram, MD, Principal Investigator, Dermatology, Cosmetic & Laser Surgery

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