Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol
Study Details
Study Description
Brief Summary
Evaluation of safety and performance of HA based injectable device for skin quality improvement
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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the effectiveness four months (M4) after treatment.
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the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
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subject's satisfaction and subject's opinion on aesthetic improvement.
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the injector's satisfaction on the injection quality.
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the safety using clinical evaluation of the Injection Site Reactions (ISR).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Device under investigation
|
Device: Dermal Filler Device
Injection of the device by investigators according to the IFU
|
Outcome Measures
Primary Outcome Measures
- Performance [1 month]
GAIS: Global Aesthetic Improvement Scale - Minimum value is 3 "Improved". Higher score is a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy Subject.
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Sex: male or female.
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Age: between 35 and 70 years.
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Subject seeking an improvement for HA skin quality improvement product.
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Subject with BMI <30.
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Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
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Subject having given his/her free, express, and informed consent.
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Subject psychologically able to understand the information related to the study, and to give their written informed consent.
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Subject registered with a social security scheme.
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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
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Pregnant or nursing woman or planning a pregnancy during the study.
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Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
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Subject in a social or sanitary establishment.
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Subject suspected to be non-compliant according to the investigator's judgment.
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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.
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Subject enrolled in another study or whose non-enrollment period is not over.
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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
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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.
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Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
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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.
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Subject with a history of streptococcal disease or an active streptococcus infection.
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Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kylane Laboratoires | Plan-les-ouates | Switzerland | 1228 |
Sponsors and Collaborators
- Kylane Laboratoires
- Eurofins Dermscan Pharmascan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23E1077