NCT01735929

Brief Summary

The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

November 5, 2012

Last Update Submit

December 2, 2021

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in photo ratings at 8 weeks.

    Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.

    Baseline and 8 weeks

Study Arms (2)

Neck Liposuction and Ultrasound Treatment

EXPERIMENTAL

Subject will receive neck liposuction and ultrasound treatment.

Procedure: Neck Liposuction and Ultrasound Treatment

Sham

SHAM COMPARATOR

Subject will receive sham treatment

Procedure: Sham Treatment

Interventions

Neck Liposuction and Ultrasound TreatmentPROCEDURE
Neck Liposuction and Ultrasound Treatment
Sham TreatmentPROCEDURE
Sham

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women 35-60 years old
  • Exhibit mild to moderate neck skin laxity on clinical examination
  • No other serious health problems, including psychiatric illness.

You may not qualify if:

  • Prior neck surgery or face lift.
  • Bleeding disorders or coagulopathy.
  • Botulinum toxin or filler injections to neck area within past 6 months.
  • Severe neck skin laxity or sagging
  • Other serious medical conditions that in the opinion of the surgeon could compromise safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 28, 2012

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

December 6, 2021

Record last verified: 2021-12