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The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrolane VRF30 | Experimental | Injection of Macrolane VRF30 in buttocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrolane VRF30 | Device | Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 | To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1 | To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS. Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation. | 1 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, M.D. | Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artemedis Center for Plastic Surgery | Sint-Denijs-Westrem | 9051 | Belgium | |||
| Centro Clinico Mir-Mir |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24076699 | Result | Camenisch CC, Tengvar M, Heden P. Macrolane for volume restoration and contouring of the buttocks: magnetic resonance imaging study on localization and degradation. Plast Reconstr Surg. 2013 Oct;132(4):522e-529e. doi: 10.1097/PRS.0b013e31829fe47e. | |
| 24464121 | Result | De Meyere B, Mir-Mir S, Penas J, Camenisch CC, Heden P. Stabilized hyaluronic acid gel for volume restoration and contouring of the buttocks: 24-month efficacy and safety. Aesthetic Plast Surg. 2014 Apr;38(2):404-12. doi: 10.1007/s00266-013-0251-9. Epub 2014 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macrolane VRF30 | Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention To Treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Macrolane VRF30 | Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject |
| 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 | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 | To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation. | Intention to treat, subjects with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
From treatment up to 24 months
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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 | Macrolane VRF30 | Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lipectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Galderma Uppsala | +46 (0)18 474 9000 | receptionen.SEUPP@galderma.com |
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| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12 |
To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS. Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation. |
| 12 Months |
| Barcelona |
| 08006 |
| Spain |
| Cirugia Plastica | Madrid | 28046 | Spain |
| Akademikliniken | Stockholm | 115 42 | Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1 | To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS. Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation. | Intention to treat, subjects with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 1 Month |
|
|
|
| Secondary | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12 | To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS. Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation. | Intention To Treat. Subjects with data available | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months |
|
|
|
| 2 |
| 61 |
| 13 |
| 61 |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
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| Implant Site Pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Implant Site Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Implant Site Haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Implant Site Swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
Any publication or presentation by PI shall be submitted to Q-Med for review no less than 60 days before submission for publication or presentation. Q-Med will provide any comments to PI within thirty (30) days following receipt of the proposed publication/presentation. PI agree to consider, discuss and give reasonable considerations to comments by Q-Med. Q-Med may also request that the Company name (or that of Q-Med employee) appear or not appear in such publication.