Skin LaxityNCT02441036

Gene Expression Following Ultherapy® Treatment

A study testing Ultherapy Treatment in people with Skin Laxity, run by Ulthera, Inc at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis. Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Skin Laxity
What is being tested?: Ultherapy Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 1 May 2015to 18 Aug 2016
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 45 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age 45 to 70 years.
Subject in good health.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
Absence of physical or psychological conditions unacceptable to the investigator.
Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period.
Willingness and ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to performance of any study-related procedure.

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Significant scarring in the area(s) to be treated that would interfere with assessing results.
Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)

Show all 34Show fewer

Inability to understand the protocol or to give informed consent.
Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
BMI equal to or greater than 30.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
Concurrent enrollment in any study involving the use of investigational devices or drugs.
Current smoker or history of smoking in the last five years.
Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
History of the following cosmetic treatments in the area(s) to be treated:
Skin tightening procedure within the past year;
Injectable filler of any type within the past:
12 months for Hyaluronic acid fillers (e.g. Restylane)
12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)
Ever for permanent fillers (e.g. Silicone, ArteFill)
Neurotoxins within the past three months;
Ablative resurfacing laser treatment within the past six months;
Nonablative, rejuvenative laser or light treatment within the past six months;
Surgical dermabrasion or deep facial peels; or
Facelifts within the past year.
History of using the following prescription medications:
Accutane or other systemic retinoids within the past six months;
Topical Retinoids within the past two weeks;
Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Campbell Facial Plastic Surgery
Mequon, Wisconsin, 53092
North Valley Plastic Surgery
Phoenix, Arizona, 85050

Other trials in United States

About this study

Official title: Evaluation of Changes in Gene Expression Following Ultherapy® Treatment

Read the detailed description

This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an Ultherapy® treatment. Subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side Ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. Treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. During an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.

Conditions: Skin Laxity
Being tested: Ultherapy Treatment
Keywords: Gene expression and protein production
Medical subject headings: Cutis Laxa

What participants receive

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

Ultherapy TreatmentDevice
Also called Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.

Study groups in NCT02441036
Study group	Role	What they receive
Group 1 - 1-3 hours prior	Active comparator	Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection. Receives: Device: Ultherapy Treatment
Group 2 - 1 day prior	Active comparator	Subjects will receive Ultherapy treatment 1 day prior to tissue resection. Receives: Device: Ultherapy Treatment
Group 3 - 3 days prior	Active comparator	Subjects will receive Ultherapy treatment 3 days prior to tissue resection. Receives: Device: Ultherapy Treatment
Group 4 - 7 days prior	Active comparator	Subjects will receive Ultherapy treatment 7 days prior to tissue resection. Receives: Device: Ultherapy Treatment
Group 5 - 45 days prior	Active comparator	Subjects will receive Ultherapy treatment 45 days prior to tissue resection. Receives: Device: Ultherapy Treatment

What is being measured

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

Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling
RNA will be extracted from treated and untreated (control) tissue samples obtained from 15 study subjects. For each subject tissue of the contra-lateral side of the face served as a control and will not receive Ultherapy treatment.
OneArray Human Gene Expression microarray will be used for microarray profiling. Clustering Analysis will be performed to identify differences between treated vs. control samples and the up and down-regulated genes will be represented in a heatmap. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Measured: 1-3 hours to up to 45 days following Ultherapy treatment
Changes in Gene Expression of Apoptotic Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 genes related to apoptosis (e.g. Annexin V, Caspacin, TNF ligands and their receptors, members of the bcl-2, caspase, IAP, TRAF, CARD, death domain, death effector domain, and CIDE families, as well as genes involved in the p53 and DNA damage pathways) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Measured: 1-3 hours to up to 45 days following Ultherapy treatment
Changes in Gene Expression of Heat Shock Proteins Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 Heat Shock Protein genes that regulate protein folding (e.g. HSP90 (81 to 99 kD), HSP70 (65 to 80 kD), HSP60 (55 to 64 kD), HSP40 (35 to 54 kD), small HSPs (=34 kD) and other chaperone cofactors) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Measured: 1-3 hours to up to 45 days following Ultherapy treatment
Changes in Protein Expression in Tissues Treated With Ultherapy Compared to Control (Untreated) Tissue by Immunohistochemistry
Protein expression of apoptotic genes and heat shock proteins of interest identified in the three previous outcomes will be analyzed. Embedded or frozen section tissues will be stained for specific proteins previously identified. The number of subjects with differentially expressed proteins in treated samples compared to control samples will be determined for every study group.
Measured: 1-3 hours to up to 45 days following Ultherapy treatment

Timeline

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

1 May 201518 Aug 2016

First posted12 May 2015 (estimated)
Study start1 May 2015
Primary completion18 Aug 2016
Study completion18 Aug 2016

Why it stopped: Terminated due to non-safety reasons

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 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02441036
Sponsor's protocol ID: ULT-140
Status last verified: Dec 2018
First submitted: 6 May 2015
Last updated: 20 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: 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

Recruiting
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Facial Skin Laxity
Recruiting
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Wrinkle, Scar
Active, not recruiting
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Rhytids, Skin Laxity
Not yet recruiting
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
Skin Laxity (Submental and Neck), Skin Lifting and Tightening
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour

All Skin Laxity trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Changes in Gene Expression Following Ultherapy® Treatment
ClinicalTrials.gov ID: NCT02441036
Acronym / sponsor ID: ULT-140
Conditions: Skin Laxity
Keywords: Gene expression and protein production
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to non-safety reasons
Enrolment: 16 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: 1 May 2015 (actual)
Primary completion: 18 Aug 2016 (actual)
Study completion: 18 Aug 2016 (actual)
First posted: 12 May 2015 (estimated)
Results: Posted 20 Feb 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group 1 - 1-3 hours prior	Active comparator	Device: Ultherapy TreatmentSubjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.
Group 2 - 1 day prior	Active comparator	Device: Ultherapy TreatmentSubjects will receive Ultherapy treatment 1 day prior to tissue resection.
Group 3 - 3 days prior	Active comparator	Device: Ultherapy TreatmentSubjects will receive Ultherapy treatment 3 days prior to tissue resection.
Group 4 - 7 days prior	Active comparator	Device: Ultherapy TreatmentSubjects will receive Ultherapy treatment 7 days prior to tissue resection.
Group 5 - 45 days prior	Active comparator	Device: Ultherapy TreatmentSubjects will receive Ultherapy treatment 45 days prior to tissue resection.

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female, age 45 to 70 years.
Subject in good health.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.

Key exclusion criteria (34 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Significant scarring in the area(s) to be treated that would interfere with assessing results.
Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) 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
Ultherapy TreatmentAlso: Ulthera System TreatmentFocused ultrasound energy delivered below the surface of the skin.	Device	Group 1 - 1-3 hours prior, Group 2 - 1 day prior, Group 3 - 3 days prior, Group 4 - 7 days prior, Group 5 - 45 days prior

Primary outcome

Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
RNA will be extracted from treated and untreated (control) tissue samples obtained from 15 study subjects. For each subject tissue of the contra-lateral side of the face served as a control and will not receive Ultherapy treatment. OneArray Human Gene Expression microarray will be used for microarray profiling. Clustering Analysis will be performed to identify differences between treated vs. control samples and the up and down-regulated genes will be represented in a heatmap. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Changes in Gene Expression of Apoptotic Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 genes related to apoptosis (e.g. Annexin V, Caspacin, TNF ligands and their receptors, members of the bcl-2, caspase, IAP, TRAF, CARD, death domain, death effector domain, and CIDE families, as well as genes involved in the p53 and DNA damage pathways) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Changes in Gene Expression of Heat Shock Proteins Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 Heat Shock Protein genes that regulate protein folding (e.g. HSP90 (81 to 99 kD), HSP70 (65 to 80 kD), HSP60 (55 to 64 kD), HSP40 (35 to 54 kD), small HSPs (=34 kD) and other chaperone cofactors) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Changes in Protein Expression in Tissues Treated With Ultherapy Compared to Control (Untreated) Tissue by Immunohistochemistry
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
Protein expression of apoptotic genes and heat shock proteins of interest identified in the three previous outcomes will be analyzed. Embedded or frozen section tissues will be stained for specific proteins previously identified. The number of subjects with differentially expressed proteins in treated samples compared to control samples will be determined for every study group.

Results and safety

Results posted to the registry on 20 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-3 Hours Before Resection	3	3
1 Day Before Resection	5	4
3 Days Before Resection	3	3
7 Days Before Resection	4	3
45 Days Before Resection	1	1

Primary outcome: Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling

Time frame: 1-3 hours to up to 45 days following Ultherapy treatment

Population analysed: Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.

Primary outcome: Changes in Gene Expression of Apoptotic Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array

Time frame: 1-3 hours to up to 45 days following Ultherapy treatment

Primary outcome: Changes in Gene Expression of Heat Shock Proteins Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array

Time frame: 1-3 hours to up to 45 days following Ultherapy treatment

Primary outcome: Changes in Protein Expression in Tissues Treated With Ultherapy Compared to Control (Untreated) Tissue by Immunohistochemistry

Time frame: 1-3 hours to up to 45 days following Ultherapy treatment

Adverse events

Time frame: Adverse events were followed for up to 45 days post-treatment or until event resolution.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1-3 Hours Before Resection	0 of 3 (0%)	0 of 3 (0%)	0 of 3
1 Day Before Resection	0 of 5 (0%)	0 of 5 (0%)	0 of 5
3 Days Before Resection	0 of 3 (0%)	0 of 3 (0%)	0 of 3
7 Days Before Resection	0 of 4 (0%)	0 of 4 (0%)	0 of 4
45 Days Before Resection	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Skin Laxity

Recruiting
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Facial Skin Laxity
Recruiting
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Wrinkle, Scar
Active, not recruiting
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Rhytids, Skin Laxity
Not yet recruiting
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
Skin Laxity (Submental and Neck), Skin Lifting and Tightening
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour

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.

Kari Larson, MBA study director

Ulthera, Inc

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultherapy Treatment in people with 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 8 inclusion and 34 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: stopped early, as of the sponsor's last update on 20 Feb 2019. 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 Feb 2019). 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?

Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling (time frame: 1-3 hours to up to 45 days following Ultherapy treatment). The study lists 4 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 NCT02441036.

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 20 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.