- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444169
Retrospective Evaluation of Combination Treatment With the Ulthera System
November 21, 2017 updated by: Ulthera, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Laguna Beach, California, United States, 92651
- Aesthetic Plastic Surgical Institute
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San Diego, California, United States, 92121
- Dermatology Cosmetic Laser Medical Associates of La Jolla
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Florida
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Coral Gables, Florida, United States, 33146
- Skin Research Institute
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Maryland
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Hunt Valley, Maryland, United States, 21030
- Maryland Laser Skin and Vein Institute
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Washington
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Spokane, Washington, United States, 99202
- Premier Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 6 months before or after Ultherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Liss Misell, PhD, Ulthera, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
May 6, 2015
First Submitted That Met QC Criteria
May 11, 2015
First Posted (Estimate)
May 14, 2015
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 21, 2017
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-144
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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