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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01708473

Enrollment

Registered

2012-10-17

Start date

2011-07-31

Completion date

2012-02-29

Last updated

2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Laxity

Brief summary

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

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

DRUGAdvil

One (1) tablet 800 mg Advil one hour prior to treatment.

DRUGLortab

One (1) tablet 10/500 mg of Lortab one hour prior to treatment.

DEVICEUlthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026