Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Study Overview
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Brief Summary
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Evaluation of safety and performance of HA based injectable device for skin quality improvement

Detailed Description
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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).

Official Title
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Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment

Conditions
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Aesthetic Dermatology

Intervention / Treatment
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* Device: Dermal Filler Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device under investigation<br> | Device: Dermal Filler Device<br>* Injection of the device by investigators according to the IFU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | GAIS: Global Aesthetic Improvement Scale - Minimum value is 3 Improved. Higher score is a better outcome. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aesthetic, dermatology