N/A
Completed N=68
Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices
Aesthetic Dermatology
Source: ClinicalTrials.gov NCT06142578 ↗
Enrolled (actual)
68
Serious AEs
2.9%
Results posted
Apr 2025
Primary outcomePrimary: Performance — 97.6 percentage of participants
Summary
The study aims to confirm the safety and effectiveness of FILLGEL devices
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance |
97.6 | — |
| SECONDARY Performance - GAIS Investigator |
94; 82.4; 95.6; 100; 96.4; 88 | — |
| SECONDARY Patients Safety |
88; 100; 47; 47; 24; 13 | — |
| SECONDARY Subject Satisfaction - GAIS Subject |
90.4; 94.1; 100; 100; 75.3; 81.9 | — |
| SECONDARY Injector Satisfaction |
100; 100; 100; 100; 100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Subject.
- Sex: male or female.
- Age: between 18 and 65 years.
- Subject seeking an improvement of her/his face aspect with Hyaluronic Acid (HA) filler.
- For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) ;
- 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;
- For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale);
- 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.
- 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 their 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 4 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 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.
- 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
Data sourced from ClinicalTrials.gov (NCT06142578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.