HealthyNCT00894244
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
A study testing Radiofrequency device in people with Healthy, run by Northwestern University at 1 site in United States.
Trial summary
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radiofrequency device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30-60 y/o
- Mild to moderate laxity of arm skin
- Skin of Fitzpatrick levels I-III
Who cannot join
- Any active local arm infections
- Scarring or abnormalities in upper arm area
- Major systemic illnesses
- Any condition with delayed wound healing
- History of psychiatrist illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.
- Conditions
- Healthy
- Being tested
- Radiofrequency device
- Keywords
- None- Normal healthy upper arm skin will be used.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency deviceDevice
One treatment pass on one arm. 2-5 treatment passes on the other
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms Receives: Device: Radiofrequency device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)
The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment
Measured: immediately following treatment and 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894244
- Sponsor's protocol ID
- STU1178
- Status last verified
- Dec 2021
- First submitted
- 5 May 2009
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
- ClinicalTrials.gov ID
- NCT00894244
- Acronym / sponsor ID
- STU1178
- Conditions
- Healthy
- Keywords
- None- Normal healthy upper arm skin will be used.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Posted 3 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Radiofrequency deviceTreatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 30-60 y/o
- Mild to moderate laxity of arm skin
- Skin of Fitzpatrick levels I-III
Key exclusion criteria (5 listed)
- Any active local arm infections
- Scarring or abnormalities in upper arm area
- Major systemic illnesses
- Any condition with delayed wound healing
- History of psychiatrist illnesses
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 |
|---|---|---|
| Radiofrequency deviceOne treatment pass on one arm. 2-5 treatment passes on the other | Device | Treatment |
Primary outcome
The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)
Time frame: immediately following treatment and 30 days after last treatment
The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency device in people with Healthy, run by Northwestern University at 1 site in United States.
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: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters) (time frame: immediately following treatment and 30 days after last treatment). 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 28 Dec 2021.