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

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

Detailed Description
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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.

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

Conditions
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Skin Laxity

Intervention / Treatment
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* Drug: Advil
* Drug: Lortab
* Device: Ulthera System Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advil with Ultherapy<br>Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment. | Drug: Advil<br>* One (1) tablet 800 mg Advil one hour prior to treatment.<br>Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultrasound treatment for skin tightening;|
| Active Comparator: Lortab with Ultherapy<br>Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment. | Drug: Lortab<br>* One (1) tablet 10/500 mg of Lortab one hour prior to treatment.<br>Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultrasound treatment for skin tightening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment discomfort | The validated NRS scale will be used to measure average pain scores reported by subject during treatment. | During treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in skin laxity | Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs. | 90 days following treatment |