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This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Volyme | Experimental | Single injection and optional touch up injection with Restylane Volyme in Midface |
|
| No intervention arm | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Volyme | Device | Subcutis injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Med AB | Shanghai | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. |
| FG001 | Group B-Restylane Volyme Treatment Arm | Including treatment arm. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. |
| FG002 | Group B- Control Arm | Including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All summaries will be done separately for Group A (20subjects) and B(148 subjects). For statistical inference, only Group B will be used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | The first 2 eligible subjects for each Treating Investigator will receive treatment as Group A. |
| BG001 | Restylane Volyme Treatment Group of Group B | Subjects assigned in this group will receive Restylane Volyme treatment at day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Responders | Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 month |
|
1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
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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 | Group A | The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung adenocarcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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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 | Dec 9, 2022 | Apr 17, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2022 | Apr 17, 2023 | SAP_003.pdf |
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| BG002 | Control Group of Group B | Subjects assigned in this group will receive no treatment at day 1, but at 6m visit. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group B-treatment Arm | Subject assigned in this group will receive Restylane Volyme treatment at D1. |
| OG002 | Group B-control Arm | Subject assigned in this group will not receive Restylane Volyme treatment at D1 but on 6M visit. |
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Group B-treatment Arm | including treatment arm A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. | 0 | 111 | 1 | 111 | 0 | 111 |
| EG002 | Group B-control Arm | including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment. | 0 | 37 | 0 | 37 | 0 | 37 |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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