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| Name | Class |
|---|---|
| Eurofins Dermscan Pharmascan | INDUSTRY |
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The study aims to confirm the safety and effectiveness of FILLGEL devices
The primary objective is to evaluate the effectiveness of the FILLGEL range used on different treated zones one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by the independent investigator. The secondary objectives of the study are to collect data for the
FILLGEL range on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | FILLGEL 0 |
|
| Group 2 | Experimental | FILLGEL 1 |
|
| Group 3 | Experimental | FILLGEL 2 |
|
| Group 4 | Experimental | FILLGEL 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Filler Device | Device | Injection of device by investigators according to the Instruction For Use (IFU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Performance - GAIS Investigator | Proportion of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%. | 6 months, 12 months |
| Patients Safety |
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Inclusion Criteria:
Healthy Subject.
Sex: male or female.
Age: between 18 and 65 years.
Subject seeking an improvement of her/his face aspect with Hyaluronic Acid (HA) filler.
For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) ;
For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) and/or subject with thin lips (score
1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an improvement of lip volume;
For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale);
For group 4: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) and/or subject seeking improvement of chin enhancement.
Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
Subject having given their free, express, and informed consent.
Subject psychologically able to understand the information related to the study, and to give their written informed consent.
Subject registered with a social security scheme.
Women of childbearing potential should use a contraceptive method considered effective since at least 4 weeks and throughout the study
Exclusion Criteria:
In terms of population
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kylane Laboratoires | Plan-les-Ouates | 1228 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | FILLGEL 0 |
| FG001 | Group 2 | FILLGEL 1 |
| FG002 | Group 3 | FILLGEL 2 |
| FG003 | Group 4 | FILLGEL 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | FILLGEL 0 |
| BG001 | Group 2 | FILLGEL 1 |
| BG002 |
| 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 | Performance | Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%. | This results is not reported per arm. It is the very purpose of the primary endpoint, to assess the performance of the overall FILLGEL range, independantly of the Arms/groups. The results were not expressed by arms/groups separately, but for the overall FILLGEL range only, as explained in the description: Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications... | Posted | Number | percentage of participants | 1 month |
|
12 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 | Device Under Investigation (Total of Groups) | All the groups Group 1: FILLGEL 0 Group 2: FILLGEL 1 Group 3: FILLGEL 2 Group 4: FILLGEL 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| spleen cyst | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ADE | Surgical and medical procedures | Non-systematic Assessment | Adverse Device Effect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Basste Hadjab, Sponsor | Kylane Laboratoires | 0225889611 | compliance@kylane.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2022 | Mar 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2022 | Mar 18, 2025 | ICF_001.pdf |
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Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication. |
| Immediatly after injection (D0), 1 month, 6 months, 12 months |
| Subject Satisfaction - GAIS Subject | Proportion of responders (subjects with a GAIS="improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%. | 1, 6, 12 months |
| Injector Satisfaction | Distribution of each item of the questionnaire answered by the injectors (injector's satisfaction on the injection quality using subjective evaluation questionnaire). The scale is "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied" or "Very satisfied" The percentage of satisfied injectors includes participants that reported being "satisfied" and "very satisfied" | After injection |
| Group 3 |
FILLGEL 2 |
| BG003 | Group 4 | FILLGEL 3 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
FILLGEL 0,1,2,3 |
|
|
| Secondary | Performance - GAIS Investigator | Proportion of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%. | Posted | Number | percentage of participants | 6 months, 12 months |
|
|
|
| Secondary | Patients Safety | Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication. | Posted | Number | percentage of at least 1 sign of ISR | Immediatly after injection (D0), 1 month, 6 months, 12 months |
|
|
|
| Secondary | Subject Satisfaction - GAIS Subject | Proportion of responders (subjects with a GAIS="improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%. | Posted | Number | percentage of participants | 1, 6, 12 months |
|
|
|
| Secondary | Injector Satisfaction | Distribution of each item of the questionnaire answered by the injectors (injector's satisfaction on the injection quality using subjective evaluation questionnaire). The scale is "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied" or "Very satisfied" The percentage of satisfied injectors includes participants that reported being "satisfied" and "very satisfied" | Posted | Number | percentage of satisfied injectors | After injection |
|
|
|
| 0 |
| 68 |
| 2 |
| 68 |
| 37 |
| 68 |
| EG001 | Group 1 | FILLGEL 0 | 0 | 17 | 1 | 17 | 7 | 17 |
| EG002 | Group 2 | FILLGEL 1 | 0 | 17 | 1 | 17 | 11 | 17 |
| EG003 | Group 3 | FILLGEL 2 | 0 | 17 | 0 | 17 | 9 | 17 |
| EG004 | Group 4 | FILLGEL 3 | 0 | 17 | 0 | 17 | 10 | 17 |
| strangulated femoral hernia | General disorders | Non-systematic Assessment |
|
| AE not device related | Surgical and medical procedures | Non-systematic Assessment |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| At 12 months |
|
| 1 month |
|
| 6 months |
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| 12 months |
|
| At 6 months |
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| At 12 months |
|
| Easiness of product positionning |
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| Immediate results |
|
| Result after massage |
|