Trial Outcomes & Findings for Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face (NCT NCT03650387)

Last Updated: 2023-12-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

207 participants

Primary outcome timeframe

At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

Results posted on

2023-12-05

Participant Flow

The multicenter study was conducted at 7 investigational sites in Germany.

A total of 209 participants were screened, out of which 207 participants were enrolled and treated.

Participant milestones

Participant milestones
Measure	RADIESSE® (+) Lidocaine: All Participants Participants received study medical device (SMD) (RADIESSE® \[+\] Lidocaine) on Day 1 with volume for each area to be treated and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations. A minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss) per participant were treated. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
Overall Study STARTED	207
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	RADIESSE® (+) Lidocaine: All Participants Participants received study medical device (SMD) (RADIESSE® \[+\] Lidocaine) on Day 1 with volume for each area to be treated and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations. A minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss) per participant were treated. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	12
Overall Study Adverse Event (Not related)	1
Overall Study Due to COVID-19 Pandemic	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RADIESSE® (+) Lidocaine: All Participants n=207 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume for each area to be treated and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations. A minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss) per participant were treated. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.
Age, Continuous	54.1 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	200 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized White	205 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

Population: The full analysis set (FAS) was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline Merz Aesthetics Scales (MAS) value of at least one treated indication was available. This outcome measure (OM) was analyzed only for participants treated for nasolabial folds.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=202 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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)	93.6 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with 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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=194 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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)	88.7 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with 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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=188 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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)	81.9 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up)

Population: The SES was the subset of all participants who were exposed to the SMD at least once. This OM was analyzed in all participants and by the subpopulations of each indication (participants treated for nasolabial folds, for marionette lines, and for cheek volume loss).

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=203 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines n=195 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss n=189 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants n=207 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)	139 Participants	133 Participants	129 Participants	142 Participants

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=202 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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) Week 4	87.6 percentage of participants	—	—	—
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) Week 24/28 (Depending Upon Touch-up)	78.2 percentage of participants	—	—	—
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) Week 48/52 (Depending Upon Touch-up)	41.6 percentage of participants	—	—	—
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) Week 72/76 (Depending Upon Touch-up)	23.3 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=194 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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) Week 72/76 (Depending Upon Touch-up)	16.0 percentage of participants	—	—	—
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) Week 4	86.6 percentage of participants	—	—	—
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) Week 24/28 (Depending Upon Touch-up)	71.6 percentage of participants	—	—	—
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) Week 48/52 (Depending Upon Touch-up)	35.6 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=188 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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) Week 4	84.6 percentage of participants	—	—	—
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) Week 24/28 (Depending Upon Touch-up)	72.9 percentage of participants	—	—	—
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) Week 48/52 (Depending Upon Touch-up)	51.6 percentage of participants	—	—	—
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) Week 72/76 (Depending Upon Touch-up)	30.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed in all participants and by the subpopulations of each indication. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure and "number analyzed" were participants who were evaluable for the outcome measure at given time points.

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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=201 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines n=193 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss n=187 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants n=205 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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) Week 4 · Very Much Improved	24 Participants	23 Participants	24 Participants	26 Participants
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) Week 4 · Much Improved	106 Participants	102 Participants	100 Participants	107 Participants
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) Week 4 · Improved	67 Participants	65 Participants	60 Participants	68 Participants
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) Week 4 · No Change	4 Participants	3 Participants	3 Participants	4 Participants
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) Week 4 · Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 4 · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 4 · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 12/16 (Depending Upon Touch-up) · Very Much Improved	32 Participants	30 Participants	30 Participants	32 Participants
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) Week 12/16 (Depending Upon Touch-up) · Much Improved	115 Participants	113 Participants	108 Participants	118 Participants
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) Week 12/16 (Depending Upon Touch-up) · Improved	43 Participants	39 Participants	40 Participants	44 Participants
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) Week 12/16 (Depending Upon Touch-up) · No Change	7 Participants	7 Participants	5 Participants	7 Participants
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) Week 12/16 (Depending Upon Touch-up) · Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 12/16 (Depending Upon Touch-up) · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 12/16 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 24/28 (Depending Upon Touch-up) · Very Much Improved	6 Participants	4 Participants	6 Participants	6 Participants
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) Week 24/28 (Depending Upon Touch-up) · Much Improved	86 Participants	87 Participants	85 Participants	89 Participants
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) Week 24/28 (Depending Upon Touch-up) · Improved	76 Participants	70 Participants	68 Participants	77 Participants
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) Week 24/28 (Depending Upon Touch-up) · No Change	24 Participants	24 Participants	19 Participants	24 Participants
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) Week 24/28 (Depending Upon Touch-up) · Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 24/28 (Depending Upon Touch-up) · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 24/28 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 48/52 (Depending Upon Touch-up) · Very Much Improved	1 Participants	0 Participants	1 Participants	1 Participants
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) Week 48/52 (Depending Upon Touch-up) · Much Improved	13 Participants	12 Participants	13 Participants	13 Participants
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) Week 48/52 (Depending Upon Touch-up) · Improved	106 Participants	105 Participants	100 Participants	109 Participants
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) Week 48/52 (Depending Upon Touch-up) · No Change	58 Participants	55 Participants	51 Participants	59 Participants
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) Week 48/52 (Depending Upon Touch-up) · Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 48/52 (Depending Upon Touch-up) · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 48/52 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 72/76 (Depending Upon Touch-up) · Very Much Improved	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 72/76 (Depending Upon Touch-up) · Much Improved	6 Participants	6 Participants	6 Participants	6 Participants
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) Week 72/76 (Depending Upon Touch-up) · Improved	64 Participants	62 Participants	61 Participants	65 Participants
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) Week 72/76 (Depending Upon Touch-up) · No Change	88 Participants	84 Participants	80 Participants	90 Participants
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) Week 72/76 (Depending Upon Touch-up) · Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 72/76 (Depending Upon Touch-up) · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 72/76 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=201 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines n=193 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss n=187 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants n=205 Participants Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
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) Week 4 · Very Much Improved	9 Participants	7 Participants	9 Participants	9 Participants
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) Week 4 · Much Improved	71 Participants	70 Participants	71 Participants	75 Participants
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) Week 4 · Improved	102 Participants	98 Participants	89 Participants	102 Participants
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) Week 4 · No Change	18 Participants	17 Participants	17 Participants	18 Participants
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) Week 4 · Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 4 · Very Much Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 12/16 (Depending Upon Touch-up) · Very Much Improved	20 Participants	19 Participants	20 Participants	20 Participants
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) Week 12/16 (Depending Upon Touch-up) · Much Improved	84 Participants	80 Participants	80 Participants	87 Participants
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) Week 12/16 (Depending Upon Touch-up) · Improved	80 Participants	78 Participants	73 Participants	81 Participants
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) Week 12/16 (Depending Upon Touch-up) · No Change	11 Participants	10 Participants	8 Participants	11 Participants
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) Week 12/16 (Depending Upon Touch-up) · Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 12/16 (Depending Upon Touch-up) · Much Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 12/16 (Depending Upon Touch-up) · Very Much Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 24/28 (Depending Upon Touch-up) · Very Much Improved	8 Participants	8 Participants	7 Participants	8 Participants
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) Week 24/28 (Depending Upon Touch-up) · Much Improved	61 Participants	59 Participants	57 Participants	63 Participants
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) Week 24/28 (Depending Upon Touch-up) · Improved	90 Participants	87 Participants	86 Participants	92 Participants
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) Week 24/28 (Depending Upon Touch-up) · No Change	27 Participants	26 Participants	22 Participants	27 Participants
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) Week 24/28 (Depending Upon Touch-up) · Worse	5 Participants	4 Participants	5 Participants	5 Participants
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) Week 24/28 (Depending Upon Touch-up) · Much Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 72/76 (Depending Upon Touch-up) · Worse	11 Participants	11 Participants	11 Participants	11 Participants
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) Week 24/28 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 4 · Worse	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 48/52 (Depending Upon Touch-up) · Very Much Improved	0 Participants	0 Participants	0 Participants	0 Participants
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) Week 48/52 (Depending Upon Touch-up) · Much Improved	26 Participants	24 Participants	23 Participants	26 Participants
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) Week 48/52 (Depending Upon Touch-up) · Improved	87 Participants	84 Participants	82 Participants	89 Participants
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) Week 48/52 (Depending Upon Touch-up) · No Change	47 Participants	46 Participants	43 Participants	49 Participants
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) Week 48/52 (Depending Upon Touch-up) · Worse	16 Participants	16 Participants	15 Participants	16 Participants
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) Week 48/52 (Depending Upon Touch-up) · Much Worse	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 48/52 (Depending Upon Touch-up) · Very Much Worse	2 Participants	2 Participants	2 Participants	2 Participants
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) Week 72/76 (Depending Upon Touch-up) · Very Much Improved	1 Participants	1 Participants	1 Participants	1 Participants
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) Week 72/76 (Depending Upon Touch-up) · Much Improved	20 Participants	21 Participants	20 Participants	21 Participants
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) Week 72/76 (Depending Upon Touch-up) · Improved	63 Participants	60 Participants	57 Participants	63 Participants
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) Week 72/76 (Depending Upon Touch-up) · No Change	61 Participants	57 Participants	56 Participants	63 Participants
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) Week 72/76 (Depending Upon Touch-up) · Much Worse	2 Participants	2 Participants	2 Participants	2 Participants
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) Week 72/76 (Depending Upon Touch-up) · Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

RADIESSE® (+) Lidocaine: Nasolabial Folds

Serious events: 5 serious events

Other events: 139 other events

Deaths: 0 deaths

RADIESSE® (+) Lidocaine: Marionette Lines

Serious events: 5 serious events

Other events: 133 other events

Deaths: 0 deaths

RADIESSE® (+) Lidocaine: Cheek Volume Loss

Serious events: 4 serious events

Other events: 129 other events

Deaths: 0 deaths

RADIESSE® (+) Lidocaine: All Participants

Serious events: 5 serious events

Other events: 142 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RADIESSE® (+) Lidocaine: Nasolabial Folds n=203 participants at risk Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of nasolabial folds. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Marionette Lines n=195 participants at risk Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of marionette lines. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: Cheek Volume Loss n=189 participants at risk Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations, and the extent of the volume loss/deficit for treatment of upper cheek volume loss. An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate.	RADIESSE® (+) Lidocaine: All Participants n=207 participants at risk Participants received SMD (RADIESSE® \[+\] Lidocaine) on Day 1 with volume and using injection techniques based on investigator's judgement, skin conditions, safety and participant's expectations and depended on the area to be treated for minimum of two and a maximum of three indications (nasolabial folds, marionette lines, cheek volume loss). An optional touch-up was performed at Week 4 (Visit 2) in the indications that were treated on Day 1, to obtain an optimal aesthetic outcome, as appropriate. Participants were included in multiple reporting arms as per treated indications. All participants reporting arm represented all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.49% 1/203 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.51% 1/195 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.53% 1/189 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.48% 1/207 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.49% 1/203 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.51% 1/195 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.53% 1/189 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.48% 1/207 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.
Infections and infestations Diverticulitis	0.49% 1/203 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.51% 1/195 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.53% 1/189 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.48% 1/207 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.49% 1/203 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.51% 1/195 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.53% 1/189 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.48% 1/207 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.
Injury, poisoning and procedural complications Ankle fracture	0.49% 1/203 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.51% 1/195 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.00% 0/189 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.	0.48% 1/207 • Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) The investigator asked the participant for AEs systematically at each visit. As planned, the cumulative data was collected for Week 72 or 76 based on the touch-up.

Other adverse events

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