Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

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.

Study Overview

• Status: Completed
• Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)
• Intervention / Treatment: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital, Merz Investigational Site #0860003
  • Beijing, China
    • Peking University Third Hospital, Merz Investigational Site #0860009
  • Guangzhou, China, 510000
    • The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023
  • Hangzhou, China, 310006
    • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005
  • Nanjing, China
    • Zhongda Hospital Southeast University, Merz Investigational Site #0860022
  • Wuhan, China, 430060
    • RenMin Hospital of Wuhan University, Merz Investigational Site #0860014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left side Radiesse® / Right side Restylane®	Device: Radiesse injectable implant (dermal filler); Subdermal injection.; Other Names: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.; Device: Restylane injectable implant (dermal filler); Subdermal injection.; Other Names: Hyaluronic acid
Experimental: Left side Restylane® / Right side Radiesse®	Device: Radiesse injectable implant (dermal filler); Subdermal injection.; Other Names: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.; Device: Restylane injectable implant (dermal filler); Subdermal injection.; Other Names: Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)	Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.	Baseline and Week 24 after last injection, up to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24	The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants.	Week 24 after last injection, up to 28 weeks
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24	The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.	Week 24 after last injection, up to 28 weeks
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse	Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.	Baseline to week 48 after last injection, up to 52 weeks

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: M900311009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes