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

Not Applicable

Completed

• Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)
• Interventions: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)

• Registration Number: NCT04647721
• Lead Sponsor: Merz North America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-01-13
• Primary Completion: 2021-11-08
• Study Completion: 2022-04-27
• Results First Submitted: 2022-11-08
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Results First Posted: 2023-01-23
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Left side Restylane® / Right side Radiesse®	Radiesse injectable implant (dermal filler)	-
Left side Restylane® / Right side Radiesse®	Restylane injectable implant (dermal filler)	-
Left side Radiesse® / Right side Restylane®	Radiesse injectable implant (dermal filler)	-
Left side Radiesse® / Right side Restylane®	Restylane injectable implant (dermal filler)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)	Baseline and Week 24 after last injection, up to 28 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse	Baseline to week 48 after last injection, up to 52 weeks	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.
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24	Week 24 after last injection, up to 28 weeks	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.
Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24	Week 24 after last injection, up to 28 weeks	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.

Trial Locations

Locations (7)

Peking University Third Hospital, Merz Investigational Site #0860009; 🇨🇳 Beijing, China

Peking University First Hospital, Merz Investigational Site #0860003; 🇨🇳 Beijing, China

Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005; 🇨🇳 Hangzhou, China

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030; 🇨🇳 Hangzhou, China

RenMin Hospital of Wuhan University, Merz Investigational Site #0860014; 🇨🇳 Wuhan, China

The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023; 🇨🇳 Guangzhou, China

Zhongda Hospital Southeast University, Merz Investigational Site #0860022; 🇨🇳 Nanjing, China