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

Study Overview
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Brief Summary
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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.

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

Conditions
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Correction of Moderate to Severe Nasolabial Folds (NLFs)

Intervention / Treatment
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* Device: Radiesse injectable implant (dermal filler)
* Device: Restylane injectable implant (dermal filler)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split-face
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |