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| Name | Class |
|---|---|
| Eurofins Dermscan Pharmascan | INDUSTRY |
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Evaluation of safety and performance of HA based injectable device for skin quality improvement
The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.
The secondary objectives of the study are to collect data on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device under investigation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Filler Device | Device | Injection of the device by investigators according to the IFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance at 1 Month Investigator Overall VISCOL Range | Primary endpoint was the percentage 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 GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Performance at 4 Months Investigator Overall VISCOL Range | Percentage of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole VISCOL range. | 4 months |
| Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range |
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Inclusion Criteria:
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 | Viscol Face | Dermal Filler Device: Injection of the device by investigators according to the IFU in Face area |
| FG001 | Viscol Body | Dermal Filler Device: Injection of the device by investigators according to the IFU in Body area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Viscol Face | Injection of the device by investigators according to the IFU in the Face area |
| BG001 | Viscol Body | Injection of the device by investigators according to the IFU in the Body area |
| 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 at 1 Month Investigator Overall VISCOL Range | Primary endpoint was the percentage 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 GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%. | Primary endpoint was the percentage of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications | Posted | Count of Participants | Participants | 1 month |
|
6 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 | Viscol Face | Dermal Filler Device: Injection of the device by investigators according to the IFU in face area |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effect | Surgical and medical procedures | Non-systematic Assessment |
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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 | Oct 26, 2023 | Mar 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2023 | Apr 14, 2025 | ICF_001.pdf |
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Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS investigator (N=95 indications). Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by an independent investigator. |
| 1 month & 4 months |
| Performance at 1 & 4 Months Subject Overall VISCOL Range | Percentage of responders for the whole VISCOL range as assessed by the subject. This percentage of responders was compared to a theoretical proportion of 60% | 1 month, 4 months |
| Percentage of Indications With Response: GAIS Subject Overall VISCOL Range | Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS subject (N=95 indications) Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by the subject. | 1 month & 4 months |
| Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range | Responder rate for the whole VISCOL range by indication at M1 and M4- GAIS combined score (investigator and subjects) (N=95 indications). It represents the percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range by indication as assessed by the subject as well as by the investigator. | 1 month & 4 months |
| Injector Satisfaction Questionnaire Viscol | Distribution of each item of the questionnaire answered by the injectors. For each item of the injector questionnaire, the percentage of answers "very satisfied" and satisfied were computed as "Satisfied" and the percentage of answers "Neither satisfied" ,or "dissatisfied", "dissatisfied" and "very dissatisfied" were computed as Dissatisfied. The measure reported is the percentage of participants who were "Satisfied". | D0 (Immediatly after injection) |
| Subject Satisfaction Questionnaire Viscol | Distribution of each item of the questionnaire answered by the subjects injected with Viscol. For each item of the subject questionnaire, the percentage of answers "totally agree" and "agree" were computed as "Agree" and the percentage of answers "Neither agree and disagree",or "disagree" and "totally disagree" and "very dissatisfied" were computed as "Disagree". The measure reported is the percentage of participants who "Agree". | 1 month, 4 months |
| Percentage of Participants Experiencing Adverse Events | Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE) | 6 months |
| BG002 | 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 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Performance at 4 Months Investigator Overall VISCOL Range | Percentage of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole VISCOL range. | 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range | Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS investigator (N=95 indications). Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by an independent investigator. | 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. Responder rate for the whole indication (N=95 indications) of VISCOL range at M1 and M4. | Posted | Number | percentage of indications | 1 month & 4 months | Indications | Indications |
|
|
|
| Secondary | Performance at 1 & 4 Months Subject Overall VISCOL Range | Percentage of responders for the whole VISCOL range as assessed by the subject. This percentage of responders was compared to a theoretical proportion of 60% | Posted | Count of Participants | Participants | 1 month, 4 months |
|
|
|
| Secondary | Percentage of Indications With Response: GAIS Subject Overall VISCOL Range | Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS subject (N=95 indications) Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by the subject. | 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. Responder rate for the whole indication (N=95 indications) of VISCOL range at M1 and M4 | Posted | Number | percentage of indications | 1 month & 4 months | Indication | Indication |
|
|
|
| Secondary | Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range | Responder rate for the whole VISCOL range by indication at M1 and M4- GAIS combined score (investigator and subjects) (N=95 indications). It represents the percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range by indication as assessed by the subject as well as by the investigator. | Responder rate for the whole VISCOL range by indication (N=95 indications) at M1 and M4- GAIS combined score (investigator and subjects). 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. | Posted | Number | percentage of responders | 1 month & 4 months | Indications | Indications |
|
|
|
| Secondary | Injector Satisfaction Questionnaire Viscol | Distribution of each item of the questionnaire answered by the injectors. For each item of the injector questionnaire, the percentage of answers "very satisfied" and satisfied were computed as "Satisfied" and the percentage of answers "Neither satisfied" ,or "dissatisfied", "dissatisfied" and "very dissatisfied" were computed as Dissatisfied. The measure reported is the percentage of participants who were "Satisfied". | Posted | Number | percentage of participants | D0 (Immediatly after injection) |
|
|
|
| Secondary | Subject Satisfaction Questionnaire Viscol | Distribution of each item of the questionnaire answered by the subjects injected with Viscol. For each item of the subject questionnaire, the percentage of answers "totally agree" and "agree" were computed as "Agree" and the percentage of answers "Neither agree and disagree",or "disagree" and "totally disagree" and "very dissatisfied" were computed as "Disagree". The measure reported is the percentage of participants who "Agree". | 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. | Posted | Number | percentage of subjects | 1 month, 4 months |
|
|
|
| Secondary | Percentage of Participants Experiencing Adverse Events | Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 26 |
| 64 |
| EG001 | Viscol Body | Dermal Filler Device: Injection of the device by investigators according to the IFU in body area | 0 | 22 | 0 | 22 | 6 | 22 |
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| Ease of injection (including extrusion force control) |
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| Handling comfort |
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| Ease of product positioning |
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| Immediate result |
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| Result after massage |
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| Improvement in skin laxity at 1 month |
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| Improvement in skin hydration at 1 month |
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| Improvement in skin roughness at 1 month |
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| Improvement in skin smoothness at 1 month |
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| Contour remodelled and more defined at 1 month |
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| Lifting effect at 1 month |
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| Improvement of skin radiance at 1 month |
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| Decrease of skin fine lines at 1 month |
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| Improvement of the aspect of skin pores at 1 month |
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| I am satisfied with the result obtained at 1 month |
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| Improvement in skin firmness at 4 months |
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| Improvement of skin elasticity/pliability at 4 months |
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| Improvement in skin laxity at 4 months |
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| Improvement in skin hydration at 4 months |
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| Improvement in skin roughness at 4 months |
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| Improvement in skin smoothness at 4 months |
|
| Contour remodelled and more defined Contour remodelled and more defined at 4 months |
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| Lifting effect at 4 months |
|
| Improvement of skin radiance at 4 months |
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| Decrease of skin fine lines at 4 months |
|
| Improvement of the aspect of skin pores at 4 months |
|
| I am satisfied with the result obtained I am satisfied with the result obtained at 4 months |
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| At least one SAE |
|