Periorbital WrinklesNCT01368900

Reducing Wrinkles Around the Eyes Using the Ulthera® System

A study testing Ulthera® System treatment in people with Periorbital Wrinkles, run by Ulthera, Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Periorbital Wrinkles
What is being tested?: Ulthera® System treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 2 sitesUnited States
Study dates: Mar 2011to Jan 2012
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female, aged 30 to 65 years.
Subject in good health.
Mild to moderate rhytids in the periorbital region.
Willingness and ability to comply with protocol requirements and return for follow-up visits.
Not pregnant.
Provide written informed consent and HIPAA authorization.

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the face.
Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
Excessive hooding, with or without redundant skin, in the areas to be treated.
Significant scarring in areas to be treated.

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Significant open facial wounds or lesions.
Severe or cystic acne on the face.
Presence of a metal stent or implant in the facial area to be treated.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

MD Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
The Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

Read the detailed description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Conditions: Periorbital Wrinkles
Being tested: Ulthera® System treatment
Keywords: Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ulthera® System treatmentDevice
Also called Ultherapy
Focused ultrasound energy delivered below the surface of the skin.

Study groups in NCT01368900
Study group	Role	What they receive
Ulthera System Treatment	Experimental	Ulthera treatment to the upper face. Receives: Device: Ulthera® System treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
Measured: 90 days post-treatment

Secondary outcomes (5)

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.
Measured: 60 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.
Measured: 90 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
1. = Very Much Improved
2. = Much Improved
3. = Improved
4. = No Change
5. = Worse
"Any Improvement" includes subjects assessed in categories 1-3.
Measured: 180 days post-treatment
Patient Satisfaction Questionnaire 90 Days Post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
Measured: 90 days post-treatment
Patient Satisfaction Questionnaire at 180 Days Post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
Measured: 180 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jan 2012

First posted8 Jun 2011 (estimated)
Study startMar 2011
Primary completionOct 2011
Study completionJan 2012

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 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368900
Sponsor's protocol ID: ULT-111
Status last verified: Sep 2013
First submitted: 6 Jun 2011
Last updated: 13 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Skin Resurfacing
Not yet recruiting
Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
Periorbital Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
Enrolling by invitation
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
Periorbital Wrinkles, Periorbital Area

All Periorbital Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes
ClinicalTrials.gov ID: NCT01368900
Acronym / sponsor ID: ULT-111
Conditions: Periorbital Wrinkles
Keywords: Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Oct 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 31 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Ulthera System Treatment	Experimental	Device: Ulthera® System treatmentUlthera treatment to the upper face.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female, aged 30 to 65 years.
Subject in good health.
Mild to moderate rhytids in the periorbital region.
Willingness and ability to comply with protocol requirements and return for follow-up visits.
Not pregnant.

Key exclusion criteria (9 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the face.
Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
Excessive hooding, with or without redundant skin, in the areas to be treated.

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® System treatmentAlso: UltherapyFocused ultrasound energy delivered below the surface of the skin.	Device	Ulthera System Treatment

Primary outcome

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Time frame: 90 days post-treatment
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.

5 secondary outcomes

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
Time frame: 60 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
Time frame: 90 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
Time frame: 180 days post-treatment
Patient Satisfaction Questionnaire 90 Days Post-treatment
Time frame: 90 days post-treatment
Patient Satisfaction Questionnaire at 180 Days Post-treatment
Time frame: 180 days post-treatment

Results and safety

Results posted to the registry on 31 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated Subjects	68	61

Primary outcome: Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes

Time frame: 90 days post-treatment. Number. Unit: percentage of participants improved

Measure	Subjects Treated n = 64
Left Eye (1.5mm Transducer)	47
Right Eye (1.0mm Transducer)	50

Population analysed: Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Subjects	0 of 68 (0%)	5 of 68 (7.4%)	Not reported

Limitations and caveats (from the sponsor): FWCS scores assessed globally, not per eye, leading to limited data for analysis. FWCS protocol amended to 3+ after enrollment of 19 subjects with FWCS of 2. Unacceptable lighting, focus, exposure making some photos impossible to evaluate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Periorbital Wrinkles

Active, not recruiting
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Skin Resurfacing
Not yet recruiting
Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
Periorbital Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
Enrolling by invitation
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
Periorbital Wrinkles, Periorbital Area

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.

Robert Weiss, M.D. principal investigator

MD Laser Skin & Vein Institute

Brian Biesman, M.D. principal investigator

The Nashville Centre for Laser and Facial Surgery

2 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 treatment in people with Periorbital Wrinkles, run by Ulthera, Inc at 2 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 6 inclusion and 9 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 31 Jul 2013). 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?

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes (time frame: 90 days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368900.

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 13 Dec 2017.