Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merz Pharmaceuticals GmbH | INDUSTRY |
Not provided
Not provided
To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 MRZF111 injection cycles | Experimental | Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16. |
|
| 2 MRZF111 injection cycles | Experimental | Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRZF111 | Device | MRZF111 kit consisting of one syringe of RADIESSE® Volume injectable implant, injection needles and additional components. Physiological saline solution (0.9% NaCl) is used to dilute Radiesse Volume by 1:2. Radiesse consists of calcium hydroxylapatite particles suspended in an aqueous-based gel carrier. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater | The percentage of responders (responder rate) was defined as greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome. | 16 weeks after the last treatment on Week 16 (at Week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF]) | The percentage of responders (responder rate) was defined as >= 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at dynamic was assessed using MAS-Dynamic Scale. The MAS-Dynamic Scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #0490189 | Bad Soden | 65812 | Germany | |||
| Merz Investigational Site #0490375 |
Not provided
Not provided
Not provided
Not provided
Not provided
Primary effectiveness analysis was done on pooled data.Further supportive explorative analyses done separately by Groups A and B for primary effectiveness outcome measure(OM) and for secondary effectiveness OM 2,but this analysis was not part of main primary effectiveness analysis.As per planned analysis based on protocol and SAP,data for secondary effectiveness outcome measures(3 to 6)were planned to be analyzed for pooled treatment groups,hence pooled data reported for these outcome measures.
This study was conducted at 9 investigational sites in Germany from 04 December 2019 to 23 February 2021. A total of 117 participants were enrolled and randomized in the study, out of which 90 participants completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A: MRZF111 (3 Injections) | Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 milliliter (mL) MRZF111 over the complete course of treatment. |
| FG001 | Group B: MRZF111 (2 Injections) | Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set (SAS) included participants who were randomized to Group A but treated according to the injection scheme of Group B due to COVID-19 pandemic measures and were analyzed in Group B. Participants who were treated only once were analyzed in Group B.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A: MRZF111 (3 Injections) | Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment. |
| BG001 | Group B: MRZF111 (2 Injections) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater | The percentage of responders (responder rate) was defined as greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome. | The modified full analysis set (FAS) included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed via multiple imputation approach) was used for pooled treatment group. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
Up to Week 52
The investigator reported adverse events systematically at each visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: MRZF111 (3 Injections) | Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Aesthetics | +1 984-301-3095 | Aesthetic.Trials@merz.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 5, 2023 | Sep 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2023 | Sep 11, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 16 weeks after the last treatment on Week 16 (at Week 32) |
| Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF) | Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The treating investigators were asked to rate their level of satisfaction with the aesthetic appearance of the participant's décolleté after treatment. The investigator responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement. | 16 weeks after the last treatment on Week 16 (at Week 32) |
| Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF) | Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The participants were asked to rate their level of satisfaction with the aesthetic appearance of their décolleté after treatment. The participants responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement. | 16 weeks after the last treatment on Week 16 (at Week 32) |
| Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF) | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS-Wrinkles to assess aesthetic improvement in participants. The assessment was performed by treating investigator by live rating using standardized pre-treatment photographs for comparison. Treating investigator was asked based on their clinical experience to rate their overall impression of change of participant's décolleté wrinkles due to treatment. The investigator responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | 16 weeks after the last treatment on Week 16 (at Week 32) |
| Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF) | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). The sGAIS-wrinkles was used to assess aesthetic improvement in the participants. The assessment was performed by the participant by live rating using standardized pre-treatment photographs for comparison. The participant was asked to rate their overall impression of change of their décolleté wrinkles due to treatment. The participant responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. | 16 weeks after the last treatment on Week 16 (at Week 32) |
| Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE) | Up to Week 52 |
| Drensteinfurt |
| 48317 |
| Germany |
| Merz Investigational Site #0490095 | Hamburg | 20146 | Germany |
| Merz Investigational Site #0490345 | Hamburg | 22609 | Germany |
| Merz Investigational Site #0490309 | Kassel | 34121 | Germany |
| Merz Investigational Site #0490371 | München | 80539 | Germany |
| Merz Investigational Site #0490372 | München | 80636 | Germany |
| Merz Investigational Site #0490362 | Potsdam | 14467 | Germany |
| Merz Investigational Site #0490367 | Wuppertal | 42287 | Germany |
| Physician Decision |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Other |
|
Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Description |
|---|
| OG000 | Group A: MRZF111 (3 Injections) | Participants received three injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1, Week 8, and Week 16. Participants received a total volume of 13.5 mL MRZF111 over the complete course of treatment. |
| OG001 | Group B: MRZF111 (2 Injections) | Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment. |
| OG002 | Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections]) | Participants received MRZF111 subdermal injection in the central part of the décolleté area (Group A: three injections on Day 1, Week 8, and Week 16; Group B: two injections on Day 1 and Week 16). Participants received a total volume of 13.5 mL (Group A) or 9.0 mL (Group B) MRZF111 over the complete course of treatment. |
|
|
|
| Secondary | Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF]) | The percentage of responders (responder rate) was defined as >= 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at dynamic was assessed using MAS-Dynamic Scale. The MAS-Dynamic Scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome. | The modified FAS included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed with LOCF) was used for pooled treatment group. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
|
|
|
| Secondary | Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF) | Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The treating investigators were asked to rate their level of satisfaction with the aesthetic appearance of the participant's décolleté after treatment. The investigator responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement. | The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
|
|
| Secondary | Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF) | Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The participants were asked to rate their level of satisfaction with the aesthetic appearance of their décolleté after treatment. The participants responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement. | The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
|
|
| Secondary | Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF) | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS-Wrinkles to assess aesthetic improvement in participants. The assessment was performed by treating investigator by live rating using standardized pre-treatment photographs for comparison. Treating investigator was asked based on their clinical experience to rate their overall impression of change of participant's décolleté wrinkles due to treatment. The investigator responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
|
|
| Secondary | Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF) | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). The sGAIS-wrinkles was used to assess aesthetic improvement in the participants. The assessment was performed by the participant by live rating using standardized pre-treatment photographs for comparison. The participant was asked to rate their overall impression of change of their décolleté wrinkles due to treatment. The participant responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. | The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 weeks after the last treatment on Week 16 (at Week 32) |
|
|
|
| Secondary | Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE) | SAS included participants who were randomized to Group A but treated according to the injection scheme of Group B due to COVID-19 pandemic measures and were analyzed in Group B. Participants who were treated only once were analyzed in Group B. | Posted | Number | percentage of participants | Up to Week 52 |
|
|
|
| 0 |
| 43 |
| 4 |
| 43 |
| 21 |
| 43 |
| EG001 | Group B: MRZF111 (2 Injections) | Participants received two injections of MRZF111, a subdermal injection in the central part of the décolleté area on Day 1 and Week 16. Participants received a total volume of 9.0 mL MRZF111 over the complete course of treatment. | 0 | 74 | 5 | 74 | 25 | 74 |
| Concussion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
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.