Periorbital WrinklesNCT00747422
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
A study testing Ulthera™ System in people with Periorbital Wrinkles, run by Ulthera, Inc at 4 sites in United States.
Trial summary
The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Wrinkles
- What is being tested?
- Ulthera™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2008to May 2009
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 40 to 70 years
- Subject in good health
- Desire improvement in periorbital wrinkles
- Subject provides informed consent and agrees to attend follow-up visits
- Subject signs a HIPPA authorization
Who cannot join
- Pregnant or lactating
- Has an active systemic or local skin disease that may alter wound healing
- Has significant scarring in test areas
- Has significant open facial wounds or lesions
- Has severe or cystic acne on the face
- Has a metal stent or implant in the face area
- Is a current smoker or has a history of smoking in last 10 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
Zel Skin and Laser Specialists
Edina, Minnesota, 55424
Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology
San Diego, California, 92130
About this study
Official title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.
Read the detailed description
The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.
- Conditions
- Periorbital Wrinkles
- Being tested
- Ulthera™ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera™ SystemDevice
ultrasound treatment
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Device: Ulthera™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of periorbital wrinkles
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital WrinklesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747422
- Sponsor's protocol ID
- ULT-102
- Status last verified
- Oct 2012
- First submitted
- 3 Sep 2008
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT00747422
- Acronym / sponsor ID
- ULT-102
- Conditions
- Periorbital Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Sep 2008 (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 look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.
Detailed description
The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: Ulthera™ System |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 40 to 70 years
- Subject in good health
- Desire improvement in periorbital wrinkles
- Subject provides informed consent and agrees to attend follow-up visits
- Subject signs a HIPPA authorization
Key exclusion criteria (7 listed)
- Pregnant or lactating
- Has an active systemic or local skin disease that may alter wound healing
- Has significant scarring in test areas
- Has significant open facial wounds or lesions
- Has severe or cystic acne on the face
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 |
|---|---|---|
| Ulthera™ Systemultrasound treatment | Device | I |
Primary outcome
reduction of periorbital wrinkles
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera™ System in people with Periorbital Wrinkles, run by Ulthera, Inc at 4 sites 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 5 inclusion and 7 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
reduction of periorbital wrinkles (time frame: 3 and 6 months). 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 24 Nov 2017.