Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
NCT ID: NCT03583359
Last Updated: 2023-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2018-08-06
2020-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment with Radiesse (+)
Radiesse (+)
Radiesse (+) for jawlines.
Control/Delayed Treatment with Radiesse (+)
Radiesse (+)
Radiesse (+) for jawlines.
Interventions
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Radiesse (+)
Radiesse (+) for jawlines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
3. Is greater than or equal to (\>=) 22 and less than or equal to (\<=) 65 years of age.
Exclusion Criteria
2. Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
22 Years
65 Years
ALL
No
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
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Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Beverly Hills, California, United States
Skin Care Center, Merz Investigational Site #0010099
Los Angeles, California, United States
Ava MD, Merz Investigational Site #0010299
Santa Monica, California, United States
Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358
Vista, California, United States
AboutSkin Research LLC, Merz Investigational Site #0010103
Greenwood Village, Colorado, United States
Skin Research Institute, Merz Investigational Site #0010101
Coral Gables, Florida, United States
Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
West Palm Beach, Florida, United States
Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418
New Orleans, Louisiana, United States
MD Laser Skin & Vein Institute, Merz Investigational Site #0010323
Hunt Valley, Maryland, United States
SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098
Chestnut Hill, Massachusetts, United States
Skinfluence Medical PC, Merz Investigational #0010421
New York, New York, United States
Bass Plastic Surgery PLLC, Merz Investigational Site #0010419
New York, New York, United States
Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194
Charlotte, North Carolina, United States
Clinical Research Center of the Carolinas, Merz Investigational Site #0010417
Charleston, South Carolina, United States
Westlake Dermatology, Merz Investigational Site #0010322
Austin, Texas, United States
Countries
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References
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Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442.
Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6.
Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M900391004
Identifier Type: -
Identifier Source: org_study_id
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