Feasibility Study: Lifting and Tightening of the Elbows | NCT01708382

Studies
Feasibility Study: Lifting and Tightening of the Elbows

NCT01708382

Sponsor

Ulthera, Inc

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Skin Laxity

Interventions

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

Sep 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Feb 2013Actual

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

Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultherapy treatment on the elbows	Experimental	All enrolled subjects will receive one Ultherapy treatment to the elbows.	Device: Ulthera System Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ulthera System Treatment	Device	Focused ultrasound energy delivered below the surface of the skin	Ultherapy treatment on the elbows

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall improvement of skin laxity in the areas treated	Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.	90 days post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Aesthetic improvement	GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.	90 and 180 days post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 21 to 65 years.
Subject in good health.
Mild to moderate skin laxity on the elbows.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria:

Presence of an active systemic or local skin disease that may affect wound healing.
Excessive subcutaneous fat around the elbows.
Excessive skin laxity around the elbows.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the area to be treated

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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
Cameron K Rokhsar, MD	New York Cosmetic, Skin, and Laser Surgery Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Cosmetic, Skin and Laser Surgery Center		New York	New York	10065	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

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Browse Branches

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