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

November 21, 2017 updated by: Ulthera, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Dermatology, Cosmetic & Laser Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Advil with Ultherapy
Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
  • Ulthera® System
  • Ultherapy™ Treatment
Drug: Advil
One (1) tablet 800 mg Advil one hour prior to treatment.
ACTIVE_COMPARATOR: Lortab with Ultherapy
Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
  • Ulthera® System
  • Ultherapy™ Treatment
Drug: Lortab
One (1) tablet 10/500 mg of Lortab one hour prior to treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment discomfort
Time Frame: During treatment
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
Time Frame: 90 days following treatment
Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
90 days following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Investigators

  • Principal Investigator: Hema Sundaram, MD, Dermatology, Cosmetic & Laser Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (ESTIMATE)

October 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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