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| Name | Class |
|---|---|
| Merz Pharmaceuticals GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RADIESSE® (+) Lidocaine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RADIESSE® (+) Lidocaine | Device | RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice |
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| 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. |
| 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. |
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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 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:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosenpark Research, Merz Investigational Site #490099 | Darmstadt | 64283 | Germany | |||
| Universität Hamburg Fachbereich Chemie Institut für Biologie und Molekularbiologie , Merz Investigational Site #490095 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35533030 | Background | Pavicic T, Sattler G, Fischer T, Dirschka T, Kerscher M, Gauglitz G, Dersch H, Kravtsov M, Heide I, Prager W. Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study. J Drugs Dermatol. 2022 May 1;21(5):481-487. doi: 10.36849/JDD.6737. |
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A total of 209 participants were screened, out of which 207 participants were enrolled and treated.
The multicenter study was conducted at 7 investigational sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2021 | May 11, 2021 |
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Rater-blinded live evaluation of scale scores (the blinded rater does not know which indications were treated)
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| 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) |
| 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) |
| Hamburg |
| 20146 |
| Germany |
| Derma Science GmbH Hamburg, Merz Investigational Site #490345 | Hamburg | 22609 | Germany |
| Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #490371 | Munich | 80539 | Germany |
| Dermatologie München-Neuhausen, Merz Investigational Site #490372 | Munich | 80636 | Germany |
| Haut-und Lasercentrum, Merz Investigational Site #0490362 | Potsdam | 14467 | Germany |
| Centroderm GmbH, Merz Investigational Site #490367 | Wuppertal | 42287 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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The safety evaluation set (SES) was the subset of all participants who were exposed to the SMD at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | RADIESSE® (+) Lidocaine: All 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | percentage of participants | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) |
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| Primary | 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. | 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 only for participants treated for marionette lines. | Posted | Number | percentage of participants | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) |
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| Primary | 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. | 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 only for participants treated for cheek volume loss. | Posted | Number | percentage of participants | At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up) |
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| Primary | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | 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). | Posted | Count of Participants | Participants | Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up) |
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| Secondary | 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. | 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 only for participants treated for nasolabial folds. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | 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 only for participants treated for marionette lines. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | 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 only for participants treated for cheek volume loss. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 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) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RADIESSE® (+) Lidocaine: Nasolabial Folds | 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. | 0 | 203 | 5 | 203 | 139 | 203 |
| EG001 | 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. | 0 | 195 | 5 | 195 | 133 | 195 |
| EG002 | 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. | 0 | 189 | 4 | 189 | 129 | 189 |
| EG003 | 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. | 0 | 207 | 5 | 207 | 142 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment | Investigator assessed serious adverse event as not related to study treatment. |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment | Investigator assessed serious adverse event as not related to study treatment. |
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| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment | Investigator assessed serious adverse event as not related to study treatment. |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment | Investigator assessed serious adverse event as not related to study treatment. |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment | Investigator assessed serious adverse event as not related to study treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2021 | May 11, 2021 | SAP_001.pdf |
| Black or African American |
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| Other |
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| OG002 | 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. |
| OG003 | 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. |
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| OG000 |
| RADIESSE® (+) Lidocaine: Nasolabial Folds |
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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| Much Improved |
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| Improved |
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| No Change |
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| Very Much Worse |
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| Much Improved |
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| Improved |
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| No Change |
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| Worse |
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| Much Worse |
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| Very Much Worse |
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