Feasibility Study: Compare the Effectiveness Between Two... | NCT01708473

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

NCT01708473

Sponsor

Ulthera, Inc

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Skin Laxity

Interventions

Advil
Lortab
Ulthera System Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2017

Last Update Posted Date

Nov 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advil with Ultherapy	Active Comparator	Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.	Drug: Advil Device: Ulthera System Treatment
Lortab with Ultherapy	Active Comparator	Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.	Drug: Lortab Device: Ulthera System Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advil	Drug	One (1) tablet 800 mg Advil one hour prior to treatment.	Advil with Ultherapy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hema Sundaram, MD	Dermatology, Cosmetic & Laser Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology, Cosmetic & Laser Surgery		Rockville	Maryland	20852	United States

Condition Browse Module

MeSH Terms

ID	Term
D003483	Cutis Laxa

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007052	Ibuprofen
C514822	oxycodone-acetaminophen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided