Facial and Neck Skin LaxityNCT01368874

Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

A study testing Ulthera® System treatment in people with Facial and Neck Skin Laxity, 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

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner 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: Facial and Neck Skin Laxity
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: 71 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.
Skin laxity in the lower face and neck.
Willingness and ability to comply with protocol requirements and return for follow-up visits.
Provides written informed consent and HIPAA authorization.

Who cannot join

Pregnant or lactating.
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the face and lower neck.
Excessive skin laxity on the face and neck.
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

Zel Skin and Laser Specialists
Edina, Minnesota, 55424
Baumann Cosmetic and Research Institute
Miami Beach, Florida, 33140

Other trials in United States

About this study

Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

Read the detailed description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Conditions: Facial and Neck Skin Laxity
Being tested: Ulthera® System treatment
Medical subject headings: Facies

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
Single treatment of focused ultrasound energy delivered below the surface of the skin.

Study groups in NCT01368874
Study group	Role	What they receive
Group A	Active comparator	Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth. Receives: Device: Ulthera® System treatment
Group B	Active comparator	Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions. Receives: Device: Ulthera® System treatment
Group C	Active comparator	Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths. Receives: Device: Ulthera® System treatment

What is being measured

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

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
Measured: 90 Days post-treatment
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
Measured: 90 Days post-treatment

Secondary outcomes (8)

Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 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 participants assessed in categories 1-3
Measured: 60 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 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 participants assessed in categories 1-3
Measured: 90 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 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 participants assessed in categories 1-3
Measured: 180 days post-treatment
Patient Satisfaction 90 Days Post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.
Measured: 90 Days post-treatment
Patient Satisfaction Questionnaire 180 Days Post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.
Measured: 180 days post-treatment
L'Oreal Photographic Scale Baseline
At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
- Horizontal neck folds (Grades 0-6)
- Neck sagging (Grades 0-7);
- Texture (Female grades 0-5; male grades 0-7);
- Ptosis (Female grades 0-5; males grades 0-7).
Measured: Baseline
L'Oreal Photographic Scale 90 Days Post-treatment
At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
- Horizontal neck folds (Grades 0-6)
- Neck sagging (Grades 0-7);
- Texture (Female grades 0-5; male grades 0-7);
- Ptosis (Female grades 0-5; males grades 0-7).
Measured: 90 Days post-treatment
L'Oreal Photographic Scale 180 Days Post-treatment
At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:
- Horizontal neck folds (Grades 0-6)
- Neck sagging (Grades 0-7);
- Texture (Female grades 0-5; male grades 0-7);
- Ptosis (Female grades 0-5; males grades 0-7).
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 Facial and Neck Skin LaxityStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368874
Sponsor's protocol ID: ULT-110
Status last verified: Apr 2014
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

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All Facial and Neck Skin Laxity 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 Lifting and Tightening the Face and Neck
ClinicalTrials.gov ID: NCT01368874
Acronym / sponsor ID: ULT-110
Conditions: Facial and Neck Skin Laxity
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 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 20 Nov 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 to obtain improvement in overall lifting and tightening of skin.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Active comparator	Device: Ulthera® System treatmentUlthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.
Group B	Active comparator	Device: Ulthera® System treatmentUlthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
Group C	Active comparator	Device: Ulthera® System treatmentUlthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female, aged 30 to 65 years.
Subject in good health.
Skin laxity in the lower face and neck.
Willingness and ability to comply with protocol requirements and return for follow-up visits.
Provides written informed consent and HIPAA authorization.

Key exclusion criteria (9 listed)

Pregnant or lactating.
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the face and lower neck.
Excessive skin laxity on the face and neck.

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: UltherapySingle treatment of focused ultrasound energy delivered below the surface of the skin.	Device	Group A, Group B, Group C

Primary outcome

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
Time frame: 90 Days post-treatment
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
Time frame: 90 Days post-treatment
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis. A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.

8 secondary outcomes

Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time frame: 60 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time frame: 90 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time frame: 180 days post-treatment
Patient Satisfaction 90 Days Post-treatment
Time frame: 90 Days post-treatment
Patient Satisfaction Questionnaire 180 Days Post-treatment
Time frame: 180 days post-treatment
L'Oreal Photographic Scale Baseline
Time frame: Baseline
L'Oreal Photographic Scale 90 Days Post-treatment
Time frame: 90 Days post-treatment
L'Oreal Photographic Scale 180 Days Post-treatment
Time frame: 180 Days post-treatment

Results and safety

Results posted to the registry on 20 Nov 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
Group A	34	31
Group B	5	5
Group C	25	24

Primary outcome: Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity

Time frame: 90 Days post-treatment. Number. Unit: participants

Measure	All Subjects Treated n = 61	Group A n = 32	Group B n = 5	Group C n = 24	Groups B/C n = 29
Value	22	10	1	11	12

Primary outcome: Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP

Time frame: 90 Days post-treatment. Number. Unit: participants

Measure	All Subjects Treated n = 42	Group A n = 16	Group B n = 5	Group C n = 21	Groups B/C n = 26
Value	22	10	1	11	12

8 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
Group A	0 of 34 (0%)	0 of 34 (0%)	Not reported
Group B	0 of 5 (0%)	0 of 5 (0%)	Not reported
Group C	0 of 25 (0%)	0 of 25 (0%)	Not reported
Groups B/C	0 of 30 (0%)	0 of 30 (0%)	Not reported

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.

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Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas
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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.

Leslie Baumann, M.D. principal investigator

Baumann Cosmetic and Research Institute

Brian Zelickson, M.D. principal investigator

Zel Skin and Laser Specialist

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 Facial and Neck Skin Laxity, 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 5 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 20 Nov 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?

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity (time frame: 90 Days post-treatment). The study lists 2 primary outcomes in all. 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 NCT01368874.

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.