Clinical trial NCT03583359: Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Official title: Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement of Jawline Contour
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-11
Enrollment: 180
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.


Eligibility criteria: Inclusion Criteria:

1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
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:

1. Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
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.

Primary outcomes:
measure: Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
timeFrame: At Week 12
measure: Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
timeFrame: Baseline up to end of study (Week 60)
Secondary outcomes:
measure: Percent Change From Baseline in Face-Q Satisfaction
timeFrame: Baseline up to Week 12
measure: Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator
timeFrame: At Week 12
measure: GAIS Scores as Assessed by Participants
timeFrame: At Week 12
measure: Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)
timeFrame: At Week 12
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
state: California
city: Los Angeles
country: United States
facility: Skin Care Center, Merz Investigational Site #0010099
state: California
city: Santa Monica
country: United States
facility: Ava MD, Merz Investigational Site #0010299
state: California
city: Vista
country: United States
facility: Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research LLC, Merz Investigational Site #0010103
state: Colorado
city: Coral Gables
country: United States
facility: Skin Research Institute, Merz Investigational Site #0010101
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
state: Florida
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418
state: Louisiana
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein Institute, Merz Investigational Site #0010323
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098
state: Massachusetts
city: New York
country: United States
facility: Skinfluence Medical PC, Merz Investigational #0010421
state: New York
city: New York
country: United States
facility: Bass Plastic Surgery PLLC, Merz Investigational Site #0010419
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194
state: North Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas, Merz Investigational Site #0010417
state: South Carolina
city: Austin
country: United States
facility: Westlake Dermatology, Merz Investigational Site #0010322
state: Texas
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.