Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face

Study Overview
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Brief Summary
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The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.

Official Title
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Open-label, Multicenter, Uncontrolled, Rater-blinded, Post-market Clinical Follow-up [PMCF] Study to Confirm Performance and Safety of RADIESSE® (+) Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines, and/or Cheek Volume Loss

Conditions
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Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines

Intervention / Treatment
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* Device: RADIESSE® (+) Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female greater than or equal to (>=) 18 years old. Participants seeking for dermal filler/volumising treatment in at least two of the following indications: Nasolabial folds; Marionette lines; Cheek volume loss. Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards. Marionette lines volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Marionette Lines Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards. Upper cheek volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Upper Cheek Fullness Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards. At least two of the inclusion criteria 3, 4, and 5 must be fulfilled. Depending on the fulfilled criteria, the respective indications will be treated. Exclusion Criteria: Any prior treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid or permanent dermal fillers in the face. Any prior facial surgery, including facial plastic surgery, thread lift, any unknown treatment, or any surgical permanent implant that could interfere with performance assessments. Prior treatment within the past 24 months with porcine based collagen fillers or with volumisers (e.g., Belotero® Volume or others) in the area to be treated. Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated. Prior treatment within the past 12 months with hyaluronic acid in the area to be treated. Prior treatment within the past 6 months with facial dermal therapies (e.g. epilation, ultraviolet irradiation, radiofrequency, facial ablative or non-ablative laser treatment, microderm abrasion, mechanical or chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage] or surgical procedures) or plans to receive this during participation in the study.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RADIESSE® (+) Lidocaine<br> | Device: RADIESSE® (+) Lidocaine<br>* RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice<br>* Other names: Radiesse® Injectable Dermal Filler with Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the Merz Nasolabial Folds Scale (MNLFS) at Week 12/16 (Depending on Touch-up) | The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of greater than or equal to (>=) 1 point in both folds (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) | 
| Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the Merz Marionette Lines Scale (MMLS) at Week 12/16 (Depending on Touch-up) | The MMLS was used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging as: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) | 
| Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the Merz Upper Cheek Fullness Scale (MUCFS) at Week 12/16 (Depending on Touch-up) | The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was a 5 point scale ranging as: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) | 
| Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) |  | Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the MNLFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) | The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both folds (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. | At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up) | 
| Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the MMLS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) | The MMLS was to be used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging from: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. | At Week 4 (prior to optional touch-up); and at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up) | 
| Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the MUCFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up) | The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was based on 5 point scale ranging from: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. | At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up) | 
| Number of Participants Based on Treating Investigator's Evaluation of the Global Aesthetic Improvement on the iGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed) | The Investigator's Global Aesthetic Improvement Scale (iGAIS) was used to assess aesthetic improvement in the participants by the treating investigator by live rating using baseline photographs for comparison. The treating investigator was asked: 'Based on your clinical experience, what is your overall impression of change of the participant's aesthetic result due to treatment, compared to the condition before the first treatment (baseline)? Please check the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating was based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. | At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up) | 
| Number of Participants Based on Participant's Evaluation of the Global Aesthetic Improvement on the sGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed) | The Subject's Global Aesthetic Improvement Scale (sGAIS) was used to assess aesthetic improvement in the participants by the participant by live rating using baseline photographs for comparison. The participant was asked: 'What is your overall impression of change of your aesthetic result due to treatment, compared to the condition before the injection? Please tick the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. | At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up) |