Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices

NCT06142578 | Completed Results

• 1 other identifier: 22E0978
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to confirm the safety and effectiveness of FILLGEL devices

Conditions

Aesthetic Dermatology

Keywords

Aesthetic; dermatology

Outcome Measures

Primary Outcomes (1)

• Performance

  Primary endpoint was the proportion 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 Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%.

  1 month

Secondary Outcomes (4)

• Performance - GAIS Investigator

  6 months, 12 months

• Patients Safety

  Immediatly after injection (D0), 1 month, 6 months, 12 months

• Subject Satisfaction - GAIS Subject

  1, 6, 12 months

• Injector Satisfaction

  After injection

Study Arms (4)

Group 1

EXPERIMENTAL

FILLGEL 0

Device: Dermal Filler Device

Group 2

EXPERIMENTAL

FILLGEL 1

Device: Dermal Filler Device

Group 3

EXPERIMENTAL

FILLGEL 2

Device: Dermal Filler Device

Group 4

EXPERIMENTAL

FILLGEL 3

Device: Dermal Filler Device

Interventions

Dermal Filler Device DEVICE

Injection of device by investigators according to the Instruction For Use (IFU)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kylane Laboratoires: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Kylane Laboratoires

Plan-les-Ouates, 1228, Switzerland

Location

Results Point of Contact

• Title: Basste Hadjab, Sponsor
• Organization: Kylane Laboratoires

compliance@kylane.com

0225889611

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 21, 2023
• Study Start: November 14, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 31, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Locations

CH (1)