Aesthetic Dermatology
Conditions
Keywords
Aesthetic, dermatology
Brief summary
The study aims to confirm the safety and effectiveness of FILLGEL devices
Detailed description
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: * the effectiveness of the range used on different treated zones six months (M6) and twelve months (M12) . * the safety using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the investigator. * subject's satisfaction and subject's opinion on aesthetic improvement on the different treated zones. * the injector's satisfaction on the injection quality using subjective evaluation questionnaire.
Interventions
DEVICEDermal Filler Device
Injection of device by investigators according to the Instruction For Use (IFU)
Sponsors
Eurofins Dermscan Pharmascan
Kylane Laboratoires
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Subject. 2. Sex: male or female. 3. Age: between 18 and 65 years. 4. 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. 5. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study. 6. Subject having given their free, express, and informed consent. 7. Subject psychologically able to understand the information related to the study, and to give their written informed consent. 8. Subject registered with a social security scheme. 9. 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 1. Pregnant or nursing woman or planning a pregnancy during the study. 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. 3. Subject in a social or sanitary establishment. 4. Subject suspected to be non-compliant according to the investigator's judgment. 5. Subject having received a total of 4.500 euros as compensations for their participation in research involving human beings in the last 12 months, including their participation in the present study. 6. Subject enrolled in another study or whose non-enrollment period is not over. 7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up…). In terms of associated pathology 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety. 9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency. 10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria …) in the 6 months before screening visit. 11. Subject with a history of streptococcal disease or an active streptococcus infection. 12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance | 1 month | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance - GAIS Investigator | 6 months, 12 months | 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%. |
| Patients Safety | Immediatly after injection (D0), 1 month, 6 months, 12 months | Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication. |
| Subject Satisfaction - GAIS Subject | 1, 6, 12 months | 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%. |
| Injector Satisfaction | After injection | 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 |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 FILLGEL 0 | 17 |
| Group 2 FILLGEL 1 | 17 |
| Group 3 FILLGEL 2 | 17 |
| Group 4 FILLGEL 3 | 17 |
| Total | 68 |
Baseline characteristics
| Characteristic | Group 2 | Group 3 | Group 4 | Group 1 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 17 Participants | 17 Participants | 68 Participants |
| Age, Continuous | 46.7 years | 56.1 years | 54.1 years | 57.7 years | 53.6 years |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment France | 17 participants | 17 participants | 17 participants | 17 participants | 68 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 17 Participants | 17 Participants | 64 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 17 | 0 / 17 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 37 / 68 | 7 / 17 | 11 / 17 | 9 / 17 | 10 / 17 |
| serious Total, serious adverse events | 2 / 68 | 1 / 17 | 1 / 17 | 0 / 17 | 0 / 17 |
Outcome results
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%.
Time frame: 1 month
Population: 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...
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Groups | Performance | 97.6 percentage of participants |
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
Time frame: After injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Groups | Injector Satisfaction | Immediate results | 100 percentage of satisfied injectors |
| All Groups | Injector Satisfaction | Result after massage | 100 percentage of satisfied injectors |
| All Groups | Injector Satisfaction | Easiness of injection | 100 percentage of satisfied injectors |
| All Groups | Injector Satisfaction | Easiness of product positionning | 100 percentage of satisfied injectors |
| Group 1 | Injector Satisfaction | Easiness of injection | 100 percentage of satisfied injectors |
| Group 1 | Injector Satisfaction | Easiness of product positionning | 100 percentage of satisfied injectors |
| Group 1 | Injector Satisfaction | Result after massage | 100 percentage of satisfied injectors |
| Group 1 | Injector Satisfaction | Immediate results | 100 percentage of satisfied injectors |
| Group 2 | Injector Satisfaction | Result after massage | 100 percentage of satisfied injectors |
| Group 2 | Injector Satisfaction | Easiness of injection | 100 percentage of satisfied injectors |
| Group 2 | Injector Satisfaction | Immediate results | 100 percentage of satisfied injectors |
| Group 2 | Injector Satisfaction | Easiness of product positionning | 100 percentage of satisfied injectors |
| Group 3 | Injector Satisfaction | Immediate results | 100 percentage of satisfied injectors |
| Group 3 | Injector Satisfaction | Result after massage | 100 percentage of satisfied injectors |
| Group 3 | Injector Satisfaction | Easiness of injection | 100 percentage of satisfied injectors |
| Group 3 | Injector Satisfaction | Easiness of product positionning | 100 percentage of satisfied injectors |
Secondary
Patients Safety
Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication.
Time frame: Immediatly after injection (D0), 1 month, 6 months, 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Groups | Patients Safety | 12 months | 6 percentage of at least 1 sign of ISR |
| All Groups | Patients Safety | 1 month | 24 percentage of at least 1 sign of ISR |
| All Groups | Patients Safety | 6 months | 0 percentage of at least 1 sign of ISR |
| All Groups | Patients Safety | Immediatly after injection (D0) | 88 percentage of at least 1 sign of ISR |
| Group 1 | Patients Safety | 1 month | 13 percentage of at least 1 sign of ISR |
| Group 1 | Patients Safety | Immediatly after injection (D0) | 100 percentage of at least 1 sign of ISR |
| Group 1 | Patients Safety | 6 months | 13 percentage of at least 1 sign of ISR |
| Group 1 | Patients Safety | 12 months | 0 percentage of at least 1 sign of ISR |
| Group 2 | Patients Safety | Immediatly after injection (D0) | 47 percentage of at least 1 sign of ISR |
| Group 2 | Patients Safety | 12 months | 0 percentage of at least 1 sign of ISR |
| Group 2 | Patients Safety | 6 months | 0 percentage of at least 1 sign of ISR |
| Group 2 | Patients Safety | 1 month | 6 percentage of at least 1 sign of ISR |
| Group 3 | Patients Safety | 1 month | 6 percentage of at least 1 sign of ISR |
| Group 3 | Patients Safety | 12 months | 0 percentage of at least 1 sign of ISR |
| Group 3 | Patients Safety | Immediatly after injection (D0) | 47 percentage of at least 1 sign of ISR |
| Group 3 | Patients Safety | 6 months | 0 percentage of at least 1 sign of ISR |
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%.
Time frame: 6 months, 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Groups | Performance - GAIS Investigator | At 6 months | 94 percentage of participants |
| All Groups | Performance - GAIS Investigator | At 12 months | 88 percentage of participants |
| Group 1 | Performance - GAIS Investigator | At 6 months | 82.4 percentage of participants |
| Group 1 | Performance - GAIS Investigator | At 12 months | 76.5 percentage of participants |
| Group 2 | Performance - GAIS Investigator | At 6 months | 95.6 percentage of participants |
| Group 2 | Performance - GAIS Investigator | At 12 months | 95.6 percentage of participants |
| Group 3 | Performance - GAIS Investigator | At 12 months | 94.1 percentage of participants |
| Group 3 | Performance - GAIS Investigator | At 6 months | 100 percentage of participants |
| Group 4 | Performance - GAIS Investigator | At 6 months | 96.4 percentage of participants |
| Group 4 | Performance - GAIS Investigator | At 12 months | 86.8 percentage of participants |
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%.
Time frame: 1, 6, 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Groups | Subject Satisfaction - GAIS Subject | At 12 months | 79.5 percentage of participants |
| All Groups | Subject Satisfaction - GAIS Subject | At 6 months | 81.9 percentage of participants |
| All Groups | Subject Satisfaction - GAIS Subject | At 1 month | 90.4 percentage of participants |
| Group 1 | Subject Satisfaction - GAIS Subject | At 1 month | 94.1 percentage of participants |
| Group 1 | Subject Satisfaction - GAIS Subject | At 6 months | 64.7 percentage of participants |
| Group 1 | Subject Satisfaction - GAIS Subject | At 12 months | 76.4 percentage of participants |
| Group 2 | Subject Satisfaction - GAIS Subject | At 6 months | 92.9 percentage of participants |
| Group 2 | Subject Satisfaction - GAIS Subject | At 1 month | 100 percentage of participants |
| Group 2 | Subject Satisfaction - GAIS Subject | At 12 months | 92.9 percentage of participants |
| Group 3 | Subject Satisfaction - GAIS Subject | At 1 month | 100 percentage of participants |
| Group 3 | Subject Satisfaction - GAIS Subject | At 12 months | 88.1 percentage of participants |
| Group 3 | Subject Satisfaction - GAIS Subject | At 6 months | 88.2 percentage of participants |
| Group 4 | Subject Satisfaction - GAIS Subject | At 6 months | 81.2 percentage of participants |
| Group 4 | Subject Satisfaction - GAIS Subject | At 1 month | 75.3 percentage of participants |
| Group 4 | Subject Satisfaction - GAIS Subject | At 12 months | 63.3 percentage of participants |