Feasibility Study: Lifting and Tightening Neck Skin in Pa... | NCT01708928

Studies
Feasibility Study: Lifting and Tightening Neck Skin in Patients

NCT01708928

Sponsor

Ulthera, Inc

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

30Actual

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

Aug 2010

Primary Completion Date

Feb 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 15, 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 22, 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 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.

Detailed Description

This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Subjects who have previous history of submentoplasty and or rhytidectomy	Device: Ulthera System Treatment
Group B	Active Comparator	Subjects naïve to submentoplasty and or rhytidectomy	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	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in submental volume	Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.	90 days post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall improvement of the submental area	Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.	90 days post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged 30 to 65 years
Subject in good health
Body Mass index of less than 30
Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
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 at Visit 1 and be willing able to use an acceptable method of birth control

Exclusion Criteria:

Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
Has an active systemic or local skin disease that may alter wound healing
Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy

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

Name	Affiliation	Role
Steven Dayan, MD	DeNova Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
DeNova Research		Chicago	Illinois	60611	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

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