Clinical trial NCT04647721: Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
Official title: Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 134
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-face
Primary purpose: TREATMENT

Brief summary: Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

Safety: To evaluate the incidence and type of adverse events and serious adverse events.


Eligibility criteria: Inclusion Criteria:

* Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
* Is ≥ 22 and ≤ 65 years of age.
* Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.

Exclusion Criteria:

* Has an acute inflammatory process or active infection at the injection site.
* Has received mid- and/or lower-facial region treatments with any dermal fillers.
* Has received facial dermal therapies.
* Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.

Primary outcomes:
measure: Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
timeFrame: Baseline and Week 24 after last injection, up to 28 weeks
Secondary outcomes:
measure: Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24
timeFrame: Week 24 after last injection, up to 28 weeks
measure: Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24
timeFrame: Week 24 after last injection, up to 28 weeks
measure: Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse
timeFrame: Baseline to week 48 after last injection, up to 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital, Merz Investigational Site #0860003
city: Beijing
country: China
facility: Peking University Third Hospital, Merz Investigational Site #0860009
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University, Merz Investigational Site #0860022
city: Wuhan
country: China
facility: RenMin Hospital of Wuhan University, Merz Investigational Site #0860014
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: