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: * 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
86
Injection of the device by investigators according to the IFU
Kylane Laboratoires
Plan-les-Ouates, Switzerland
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
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
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
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
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
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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
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)
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
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