Skin LaxityNCT01735929
Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening
A study testing Neck Liposuction and Ultrasound Treatment in people with Skin Laxity, run by Northwestern University.
Trial summary
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Neck Liposuction and Ultrasound Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 35-60 years old
- Exhibit mild to moderate neck skin laxity on clinical examination
- No other serious health problems, including psychiatric illness.
Who cannot join
- 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
About this study
Official title: Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.
- Conditions
- Skin Laxity
- Being tested
- Neck Liposuction and Ultrasound Treatment, Sham Treatment
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck Liposuction and Ultrasound TreatmentProcedure or surgery
Sham TreatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neck Liposuction and Ultrasound Treatment | Experimental | Subject will receive neck liposuction and ultrasound treatment. Receives: Procedure: Neck Liposuction and Ultrasound Treatment |
| Sham | Sham comparator | Subject will receive sham treatment Receives: Procedure: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMar 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735929
- Sponsor's protocol ID
- STU68167
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2012
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction
- ClinicalTrials.gov ID
- NCT01735929
- Acronym / sponsor ID
- STU68167
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Liposuction and Ultrasound Treatment | Experimental | Procedure: Neck Liposuction and Ultrasound TreatmentSubject will receive neck liposuction and ultrasound treatment. |
| Sham | Sham comparator | Procedure: Sham TreatmentSubject will receive sham treatment |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women 35-60 years old
- Exhibit mild to moderate neck skin laxity on clinical examination
- No other serious health problems, including psychiatric illness.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck Liposuction and Ultrasound Treatment | Procedure or surgery | Neck Liposuction and Ultrasound Treatment |
| Sham Treatment | Procedure or surgery | Sham |
Primary outcome
Change from baseline in photo ratings at 8 weeks.
Time frame: Baseline and 8 weeks
Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Neck Liposuction and Ultrasound Treatment in people with Skin Laxity, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in photo ratings at 8 weeks. (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.