Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices
Study Details
Study Description
Brief Summary
The study aims to confirm the safety and effectiveness of FILLGEL devices
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary objective is to evaluate the effectiveness of the FILLGEL range used on different treated zones one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by the independent investigator. The secondary objectives of the study are to collect data for the
FILLGEL range on:
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the effectiveness of the range used on different treated zones six months (M6) and twelve months (M12) .
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the safety using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the investigator.
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subject's satisfaction and subject's opinion on aesthetic improvement on the different treated zones.
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the injector's satisfaction on the injection quality using subjective evaluation questionnaire.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Device under investigation
|
Device: Dermal Filler Device
Injection of 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 18 and 65 years.
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Subject seeking an improvement of her/his face aspect with HA filler.
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For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) ;
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For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) and/or subject with thin lips (score
1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an improvement of lip volume;
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For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale);
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For group 4: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) and/or subject seeking improvement of chin enhancement.
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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 their 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 4 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 4.500 euros as compensations for their participation in research involving human beings 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.- 22E0978