Retrospective Evaluation of Combination Treatment With the Ulthera System



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:25 - 70
Updated:11/25/2017
Start Date:April 2015
End Date:July 2015

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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.

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.

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.
We found this trial at
5
sites
Hunt Valley, Maryland 21030
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Hunt Valley, MD
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Coral Gables, Florida 33146
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Coral Gables, FL
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Laguna Beach, California 92651
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Laguna Beach, CA
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San Diego, CA
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Spokane, Washington 99204
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Spokane, WA
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