Aesthetic Dermatology
Conditions
Keywords
Aesthetic, dermatology
Brief summary
Evaluation of safety and performance of HA based injectable device for skin quality improvement
Detailed description
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: * the effectiveness four months (M4) after treatment. * the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®. * subject's satisfaction and subject's opinion on aesthetic improvement. * the injector's satisfaction on the injection quality. * the safety using clinical evaluation of the Injection Site Reactions (ISR).
Interventions
DEVICEDermal Filler Device
Injection of the device by investigators according to the IFU
Sponsors
Eurofins Dermscan Pharmascan
Kylane Laboratoires
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Subject. 2. Sex: male or female. 3. Age: between 35 and 70 years. 4. Subject seeking an improvement for HA skin quality improvement product. 5. Subject with BMI \<30. 6. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study. 7. Subject having given his/her free, express, and informed consent. 8. Subject psychologically able to understand the information related to the study, and to give their written informed consent. 9. Subject registered with a social security scheme. 10. Women of childbearing potential should use a contraceptive method considered effective since at least 12 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 6.000 euros as compensations for their participation in clinical research 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 at 1 Month Investigator Overall VISCOL Range | 1 month | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range | 1 month & 4 months | 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. |
| Performance at 1 & 4 Months Subject Overall VISCOL Range | 1 month, 4 months | 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% |
| Percentage of Indications With Response: GAIS Subject Overall VISCOL Range | 1 month & 4 months | 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. |
| Performance at 4 Months Investigator Overall VISCOL Range | 4 months | Percentage of responders (subjects with a GAIS improved, much improved and very much improved) for the whole VISCOL range. |
| Injector Satisfaction Questionnaire Viscol | D0 (Immediatly after injection) | 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. |
| Subject Satisfaction Questionnaire Viscol | 1 month, 4 months | 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. |
| Percentage of Participants Experiencing Adverse Events | 6 months | Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE) |
| Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range | 1 month & 4 months | 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. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Viscol Face Injection of the device by investigators according to the IFU in the Face area | 64 |
| Viscol Body Injection of the device by investigators according to the IFU in the Body area | 22 |
| Total | 86 |
Baseline characteristics
| Characteristic | Viscol Body | Total | Viscol Face |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 86 Participants | 64 Participants |
| Age, Continuous | 57 years | 54 years | 53 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 22 Participants | 86 Participants | 64 Participants |
| Sex: Female, Male Female | 21 Participants | 76 Participants | 55 Participants |
| Sex: Female, Male Male | 1 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 22 |
| other Total, other adverse events | 26 / 64 | 6 / 22 |
| serious Total, serious adverse events | 0 / 64 | 0 / 22 |
Outcome results
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%.
Time frame: 1 month
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viscol Face and Body | Performance at 1 Month Investigator Overall VISCOL Range | 77 Participants |
p-value: <0.0001t-test, 2 sided
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.
Time frame: D0 (Immediatly after injection)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Handling comfort | 100 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Ease of removal of the tip-cap | 100 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Ease of product positioning | 100 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Immediate result | 100 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Ease of injection (including extrusion force control) | 100 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Result after massage | 96.9 percentage of participants |
| Viscol Face and Body | Injector Satisfaction Questionnaire Viscol | Ease of needle/cannula assembly with the syringe | 100 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Result after massage | 100 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Ease of removal of the tip-cap | 100 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Ease of needle/cannula assembly with the syringe | 100 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Ease of injection (including extrusion force control) | 51.7 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Handling comfort | 100 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Immediate result | 96.5 percentage of participants |
| Viscol Body | Injector Satisfaction Questionnaire Viscol | Ease of product positioning | 100 percentage of participants |
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.
Time frame: 1 month & 4 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viscol Face and Body | Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range | At 1 month | 85 percentage of indications |
| Viscol Face and Body | Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range | At 4 months | 78 percentage of indications |
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.
Time frame: 1 month & 4 months
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viscol Face and Body | Percentage of Indications With Response: GAIS Subject Overall VISCOL Range | At 1 month | 80 percentage of indications |
| Viscol Face and Body | Percentage of Indications With Response: GAIS Subject Overall VISCOL Range | At 4 months | 70 percentage of indications |
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)
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Viscol Face and Body | Percentage of Participants Experiencing Adverse Events | At least one AE | 26 Participants |
| Viscol Face and Body | Percentage of Participants Experiencing Adverse Events | At least one ADE | 4 Participants |
| Viscol Face and Body | Percentage of Participants Experiencing Adverse Events | At least one SAE | 0 Participants |
| Viscol Body | Percentage of Participants Experiencing Adverse Events | At least one AE | 6 Participants |
| Viscol Body | Percentage of Participants Experiencing Adverse Events | At least one ADE | 0 Participants |
| Viscol Body | Percentage of Participants Experiencing Adverse Events | At least one SAE | 0 Participants |
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.
Time frame: 1 month & 4 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viscol Face and Body | Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range | At 1 month | 73 percentage of responders |
| Viscol Face and Body | Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range | At 4 months | 64 percentage of responders |
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%
Time frame: 1 month, 4 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Viscol Face and Body | Performance at 1 & 4 Months Subject Overall VISCOL Range | 1 month | 69 Participants |
| Viscol Face and Body | Performance at 1 & 4 Months Subject Overall VISCOL Range | 4 months | 62 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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viscol Face and Body | Performance at 4 Months Investigator Overall VISCOL Range | 69 Participants |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 month, 4 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Contour remodelled and more defined at 1 month | 54.7 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin elasticity/pliability at 1 month | 76.2 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin laxity at 1 month | 51.6 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin hydration at 1 month | 70.3 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin roughness at 1 month | 53.1 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin smoothness at 1 month | 68.8 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin firmness at 1 month | 64.1 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Lifting effect at 1 month | 57.1 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin radiance at 1 month | 68.8 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Decrease of skin fine lines at 1 month | 65.6 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of the aspect of skin pores at 1 month | 67.2 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | I am satisfied with the result obtained at 1 month | 79.7 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin firmness at 4 months | 68.3 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin elasticity/pliability at 4 months | 68.3 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin laxity at 4 months | 49.2 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin hydration at 4 months | 73 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin roughness at 4 months | 65.1 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin smoothness at 4 months | 74.6 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Contour remodelled and more defined Contour remodelled and more defined at 4 months | 47.6 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Lifting effect at 4 months | 54 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin radiance at 4 months | 69.8 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Decrease of skin fine lines at 4 months | 61.9 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | Improvement of the aspect of skin pores at 4 months | 69.8 percentage of subjects |
| Viscol Face and Body | Subject Satisfaction Questionnaire Viscol | I am satisfied with the result obtained I am satisfied with the result obtained at 4 months | 68.3 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of the aspect of skin pores at 4 months | 36.4 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin firmness at 1 month | 63.6 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin firmness at 4 months | 68.2 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin elasticity/pliability at 1 month | 68.2 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Contour remodelled and more defined Contour remodelled and more defined at 4 months | 27.3 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin laxity at 1 month | 59.1 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin elasticity/pliability at 4 months | 68.2 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin hydration at 1 month | 63.6 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Decrease of skin fine lines at 4 months | 40.9 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin roughness at 1 month | 47.6 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin laxity at 4 months | 54.5 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin smoothness at 1 month | 63.6 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Lifting effect at 4 months | 50 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Contour remodelled and more defined at 1 month | 31.8 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin hydration at 4 months | 68.2 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Lifting effect at 1 month | 50 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | I am satisfied with the result obtained I am satisfied with the result obtained at 4 months | 38.2 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin radiance at 1 month | NA percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin roughness at 4 months | 54.5 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Decrease of skin fine lines at 1 month | 59.1 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of skin radiance at 4 months | NA percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement of the aspect of skin pores at 1 month | 50 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | Improvement in skin smoothness at 4 months | 57.1 percentage of subjects |
| Viscol Body | Subject Satisfaction Questionnaire Viscol | I am satisfied with the result obtained at 1 month | 68.2 percentage of subjects |