Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Not Applicable

Completed

Conditions: Aesthetic Dermatology

Registration Number: NCT06142643

Lead Sponsor: Kylane Laboratoires

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

Healthy Subject.
Sex: male or female.
Age: between 35 and 70 years.
Subject seeking an improvement for HA skin quality improvement product.
Subject with BMI <30.
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 his/her 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 12 weeks and throughout the study

Exclusion Criteria

In terms of population

Pregnant or nursing woman or planning a pregnancy during the study.
Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
Subject in a social or sanitary establishment.
Subject suspected to be non-compliant according to the investigator's judgment.
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.
Subject enrolled in another study or whose non-enrollment period is not over.
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
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.
Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
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.
Subject with a history of streptococcal disease or an active streptococcus infection.
Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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)