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This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Perlane Lidocaine | Experimental | Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface |
|
| No intervention arm | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Perlane Lidocaine | Device | Intradermal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale | The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months. Medicis Midface Volume Scale (MMVS) is a 4-grade scale 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35925834 | Derived | Wang X, Wu Y, Li B, Mu X, Li L. Lifting the midface using a hyaluronic acid filler with lidocaine: A randomized multi-center study in a Chinese population. J Cosmet Dermatol. 2022 Dec;21(12):6710-6716. doi: 10.1111/jocd.15286. Epub 2022 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Perlane Lidocaine | Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection |
| FG001 | No Intervention Arm | No treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Perlane Lidocaine | Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection |
| BG001 | No Intervention Arm |
| 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 | Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale | The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months. Medicis Midface Volume Scale (MMVS) is a 4-grade scale 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.
| All summaries will be done separately for Group A and B. For statistical inference,only Group B will be used. | Posted | Count of Participants | Participants | 6 month |
1 year.
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 | Restylane Perlane Lidocaine | Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection |
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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 | Sep 7, 2016 | May 31, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2017 | Jun 1, 2023 | SAP_003.pdf |
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No treatment
| BG002 | 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 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Restylane Perlane Lidocaine | Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection |
| OG001 | No Intervention Arm | No treatment |
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | No Intervention Arm | No treatment | 0 | 37 | 0 | 37 | 0 | 37 |
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