Skin Laxity Clinical Trial
Official title:
Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
Verified date | August 2015 |
Source | Merz Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
Status | Completed |
Enrollment | 101 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Skin Research Institute | Coral Gables | Florida |
United States | Maryland Laser Skin and Vein Institute | Hunt Valley | Maryland |
United States | Aesthetic Plastic Surgical Institute | Laguna Beach | California |
United States | Dermatology Cosmetic Laser Medical Associates of La Jolla | San Diego | California |
United States | Premier Clinical Research | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within 6 months before or after Ultherapy |
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