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

Primary Purpose

Skin Laxity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Advil

Lortab

Ulthera System Treatment

About this trial

This is an interventional treatment trial for Skin Laxity

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dermatology, Cosmetic & Laser Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Advil with Ultherapy

Lortab with Ultherapy

Arm Description

Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.

Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.

Outcomes

Primary Outcome Measures

Treatment discomfort

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

Secondary Outcome Measures

Improvement in skin laxity

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

Full Information

NCT ID

NCT01708473

First Posted

October 15, 2012

Last Updated

November 21, 2017

Sponsor

Ulthera, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01708473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ulthera, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Laxity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Advil with Ultherapy

Arm Type

Active Comparator

Arm Description

Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.

Arm Title

Lortab with Ultherapy

Arm Type

Active Comparator

Arm Description

Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.

Intervention Type

Drug

Intervention Name(s)

Advil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lortab

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Ulthera System Treatment

Other Intervention Name(s)

Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Intervention Description

Focused ultrasound energy delivered below the surface of the skin

Primary Outcome Measure Information:

Title

Treatment discomfort

Description

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

Time Frame

During treatment

Secondary Outcome Measure Information:

Title

Improvement in skin laxity

Description

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

Time Frame

90 days following treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hema Sundaram, MD

Organizational Affiliation

Dermatology, Cosmetic & Laser Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology, Cosmetic & Laser Surgery

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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