Skin LaxityNCT02444169
Retrospective Evaluation of Combination Treatment With the Ulthera System
An observational study of Skin Laxity, run by Ulthera, Inc at 5 sites in United States.
Trial summary
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ultherapy, Incobotulinumtoxin A and Radiesse
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 101 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2015to Jul 2015
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults between 25 and 70 years of age who have received an Ultherapy treatment and toxin/filler within the last two years within six months apart and meet the inclusion/exclusion criteria.
Who may be able to join
- Male or female, age 25 to 70 years.
- Subject in good health
- Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.
- Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.
- Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.
- Subjects who are identified with good photography, must have the ability to be contacted to provide authorization to disclose photographs for usage of previously taken photography, if photos are deemed worthy of publication.
Who cannot join
- Subjects who have had any and all Ultherapy treatment(s) before April 2013.
- Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.
- Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Skin Research Institute
Coral Gables, Florida, 33146
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, 21030
Aesthetic Plastic Surgical Institute
Laguna Beach, California, 92651
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, 92121
Premier Clinical Research
Spokane, Washington, 99202
About this study
Official title: Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
Read the detailed description
This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.
- Conditions
- Skin Laxity
- Being tested
- Ultherapy, Incobotulinumtoxin A, Radiesse, Belotero Balance
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltherapyDevice
Also called Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Incobotulinumtoxin ADrug
Also called Xeomin
An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.
RadiesseDevice
Also called Volumizing filler
An injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth).
Belotero BalanceDevice
Also called Dermal filler
An injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers.
Measured: Within 6 months before or after Ultherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liss Misell, PhD, Study director, Ulthera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444169
- Sponsor's protocol ID
- ULT-144
- Status last verified
- Aug 2015
- First submitted
- 6 May 2015
- 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
- Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
- ClinicalTrials.gov ID
- NCT02444169
- Acronym / sponsor ID
- ULT-144
- Conditions
- Skin Laxity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 May 2015 (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.
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
Detailed description
This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 25 and 70 years of age who have received an Ultherapy treatment and toxin/filler within the last two years within six months apart and meet the inclusion/exclusion criteria.
Key inclusion criteria (6 listed)
- Male or female, age 25 to 70 years.
- Subject in good health
- Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.
- Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.
- Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.
Key exclusion criteria (3 listed)
- Subjects who have had any and all Ultherapy treatment(s) before April 2013.
- Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.
- Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.
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 |
|---|---|---|
| UltherapyAlso: Ulthera System TreatmentFocused ultrasound energy delivered below the surface of the skin. | Device | – |
| Incobotulinumtoxin AAlso: XeominAn injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. | Drug | – |
| RadiesseAlso: Volumizing fillerAn injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth). | Device | – |
| Belotero BalanceAlso: Dermal fillerAn injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth). | Device | – |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Within 6 months before or after Ultherapy
An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers.
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.
Liss Misell, PhD study director
Ulthera, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Laxity, run by Ulthera, Inc at 5 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 3 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 5 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Within 6 months before or after Ultherapy). 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.