Chest WrinklesNCT01713686

Evaluation of the Ulthera System for the Treatment of the Decolletage

A study testing Ulthera System Treatment in people with Chest Wrinkles, run by Ulthera, Inc at 4 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 is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit. Read more about this study

Who is it for?: Ages 35 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Chest 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: 129 participants
Where: 4 sitesUnited States
Study dates: Oct 2012to Aug 2013
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 35 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female, aged 35 to 70 years.
Subject in good health.
Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
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.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.

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Absence of physical conditions unacceptable to the investigator.
Willingness and ability to provide written consent for study-required photography.
Willingness and ability to provide written informed consent.

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Any open wounds or lesions in the area.
Active and severe inflammatory acne in the region to be treated.

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Patients who have a history with keloid formation or hypertrophic scarring.
Inability to understand the protocol or to give informed consent.
Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Subjects who 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 one year.
History of using the following prescription medications:
Topical Retinoids to the area within the past two weeks;
Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Denova Research
Chicago, Illinois, 60611
Tennessee Research Center
Nashville, Tennessee, 37215
Laser Skin and Surgery Center of Northern California
Sacramento, California, 95816
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121

Other trials in United States

About this study

Official title: Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage

Conditions: Chest Wrinkles
Being tested: Ulthera System Treatment
Keywords: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)

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 NCT01713686
Study group	Role	What they receive
Ulthera System Treatment	Experimental	A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Receives: Device: Ulthera System Treatment

What is being measured

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

Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
"Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
"Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Measured: 90 Days post-treatment
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.
"Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
"Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Measured: 180 days post treatment

Secondary outcomes (4)

Overall Aesthetic Improvement at 90 Days Post-treatment
The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
1. Very much improved
2. Much improved
3. Improved
4. No change
5. Worse
The scale was completed in two steps:
- Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
- Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.
"Improved" = Very Much Improved + Much Improved + Improved
Measured: 90 days post-treatment
Overall Aesthetic Improvement at 180 Days Post-treatment
The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
1. Very much improved
2. Much improved
3. Improved
4. No change
5. Worse
The scale was completed in two steps:
- Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
- Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.
"Improved" = Very Much Improved + Much Improved + Improved
Measured: 180 days post-treatment
Subject Satisfaction at 90 Days Post-treatment
Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
1. Very Satisfied
2. Satisfied
3. Neither Satisfied or Dissatisfied
4. Dissatisfied
5. Very Dissatisfied
"Satisfied"= Very Satisfied + Satisfied
"Dissatisfied"=Dissatisfied + Very Dissatisfied
Measured: 90 days post-treatment
Subject Satisfaction at 180 Days Post-treatment
Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
1. Very Satisfied
2. Satisfied
3. Neither Satisfied or Dissatisfied
4. Dissatisfied
5. Very Dissatisfied
"Satisfied" = Very Satisfied + Satisfied
"Dissatisfied" = Dissatisfied + Very Dissatisfied
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.

Oct 2012Aug 2013

First posted25 Oct 2012 (estimated)
Study startOct 2012
Primary completionAug 2013
Study completionAug 2013

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 Chest 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: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01713686
Sponsor's protocol ID: ULT-129
Status last verified: Nov 2017
First submitted: 22 Oct 2012
Last updated: 11 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage
ClinicalTrials.gov ID: NCT01713686
Acronym / sponsor ID: ULT-129
Conditions: Chest Wrinkles
Keywords: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 25 Oct 2012 (estimated)
Results: Posted 9 Mar 2015

Clinical summary

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

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 TreatmentA single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.

Who may qualify

Ages: 35 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Female, aged 35 to 70 years.
Subject in good health.
Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
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.

Key exclusion criteria (21 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Any open wounds or lesions in the area.

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: Ultherapy™Focused ultrasound energy delivered below the surface of the skin	Device	Ulthera System Treatment

Primary outcome

Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
Time frame: 90 Days post-treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
Time frame: 180 days post treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

4 secondary outcomes

Overall Aesthetic Improvement at 90 Days Post-treatment
Time frame: 90 days post-treatment
Overall Aesthetic Improvement at 180 Days Post-treatment
Time frame: 180 days post-treatment
Subject Satisfaction at 90 Days Post-treatment
Time frame: 90 days post-treatment
Subject Satisfaction at 180 Days Post-treatment
Time frame: 180 days post-treatment

Results and safety

Results posted to the registry on 9 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ulthera System Treatment	125	110

Primary outcome: Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment

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

Measure	Ulthera System Treatment n = 113
Improvement	69.9
No change	15.9
Incorrect	14.2

Population analysed: The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as 'missing' by the statistician and were not included in the denominator for the masked assessment analyses.

Primary outcome: Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment

Time frame: 180 days post treatment. Number. Unit: percentage of participants

Measure	Ulthera System Treatment n = 116
Improved	66.4
No Change	11.2
Incorrect	22.4

Population analysed: The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were followed for up to 6 months post-treatment or until event resolution.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ulthera System Treatment	0 of 125 (0%)	83 of 125 (66.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Mitchel P Goldman, MD principal investigator

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

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 Treatment in people with Chest 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 9 inclusion and 21 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 11 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 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?

Yes. Results are posted in the registry (first posted 9 Mar 2015). 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?

Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment (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 NCT01713686.

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 11 Dec 2017.