Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.
Safety: To evaluate the incidence and type of adverse events and serious adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left side Radiesse® / Right side Restylane® | Experimental |
| |
| Left side Restylane® / Right side Radiesse® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse injectable implant (dermal filler) | Device | Subdermal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) | Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome. | Baseline and Week 24 after last injection, up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24 | The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants. |
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 |
|---|---|---|---|---|---|---|
| Peking University First Hospital, Merz Investigational Site #0860003 | Beijing | 100034 | China | |||
| Peking University Third Hospital, Merz Investigational Site #0860009 |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 134 enrolled, 13 subjects were exited as screen failures. This reporting group includes all randomized subjects (121).
Subjects were recruited from 7 investigational sites in China.
| ID | Title | Description |
|---|---|---|
| FG000 | Left Side Radiesse® / Right Side Restylane® | Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection. |
| FG001 | Left Side Restylane® / Right Side Radiesse® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Nov 1, 2022 | Nov 7, 2022 |
Not provided
Not provided
Split-face
Not provided
Not provided
Not provided
|
| Restylane injectable implant (dermal filler) | Device | Subdermal injection. |
|
|
| Week 24 after last injection, up to 28 weeks |
| Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24 | The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants. | Week 24 after last injection, up to 28 weeks |
| Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse | Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible. | Baseline to week 48 after last injection, up to 52 weeks |
| Beijing |
| China |
| The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023 | Guangzhou | 510000 | China |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030 | Hangzhou | 310006 | China |
| Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005 | Hangzhou | 310014 | China |
| Zhongda Hospital Southeast University, Merz Investigational Site #0860022 | Nanjing | China |
| RenMin Hospital of Wuhan University, Merz Investigational Site #0860014 | Wuhan | 430060 | China |
Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection.
| Safety Population | 1 subject randomized to Left side Restylane® / RIght side Radiesse® did not receive any treatment and was excluded from the safety population. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
This analysis population includes all randomized subjects who received investigational product at least once (Safety Population).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiesse and Restylane | Subjects were randomized to receive Radiesse in either of the two nasolabial folds and Restylane in the respective other. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 | Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) | Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome. | This analysis population includes all randomized and treated subjects with no major protocol deviations or other events that impact analysis of the primary effectiveness endpoint (Per Protocol Set) with observed cases at the Week 24 visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 24 after last injection, up to 28 weeks | NLFs | NLFs |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24 | The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants. | Subjects in the Per Protocol Set with observed cases at the Week 24 visit. | Posted | Number | percentage of participants | Week 24 after last injection, up to 28 weeks | NLFs | NLFs |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24 | The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants. | Subjects in the Per Protocol Set with observed cases at the Week 24 visit. | Posted | Number | percentage of participants | Week 24 after last injection, up to 28 weeks | NLFs | NLFs |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse | Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible. | Safety Population | Posted | Count of Participants | Participants | No | Baseline to week 48 after last injection, up to 52 weeks |
|
|
From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks
The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
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 | Restylane | Events affecting the NLF treated with Restylane | 0 | 120 | 0 | 120 | 7 | 120 |
| EG001 | Radiesse | Events affecting the NLF treated with Radiesse | 0 | 120 | 0 | 120 | 18 | 120 |
| EG002 | Non-NLF | Subjects with events not affecting either of the two NLFs | 0 | 120 | 7 | 120 | 9 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Aesthetics | +49 69 1503 1 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2022 | Nov 7, 2022 | SAP_001.pdf |
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Week 24 |
|
|
| Participants |
|
| NLFs |
|
|
|
|
| NLFs |
|
|
|
|