Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices

Safety and Effectiveness Clinical Evaluation of the Range of Injectable Medical Devices Fillgel in Facial Aesthetic Treatment

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

Study Overview

• Status: Completed
• Conditions: Aesthetic Dermatology
• Intervention / Treatment: Device: Dermal Filler Device

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:

• the effectiveness of the range used on different treated zones six months (M6) and twelve months (M12) .
• the safety using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the investigator.
• subject's satisfaction and subject's opinion on aesthetic improvement on the different treated zones.
• the injector's satisfaction on the injection quality using subjective evaluation questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Plan-les-ouates, Switzerland, 1228
    • Kylane Laboratoires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy Subject.
2. Sex: male or female.
3. Age: between 18 and 65 years.

4. 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.
5. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
6. Subject having given their free, express, and informed consent.
7. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
8. Subject registered with a social security scheme.
9. 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

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
3. Subject in a social or sanitary establishment.
4. Subject suspected to be non-compliant according to the investigator's judgment.
5. 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.
6. Subject enrolled in another study or whose non-enrollment period is not over.
7. 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
8. 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.
9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
10. 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.
11. Subject with a history of streptococcal disease or an active streptococcus infection.
12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; FILLGEL 0	Device: Dermal Filler Device; Injection of device by investigators according to the Instruction For Use (IFU)
Experimental: Group 2; FILLGEL 1	Device: Dermal Filler Device; Injection of device by investigators according to the Instruction For Use (IFU)
Experimental: Group 3; FILLGEL 2	Device: Dermal Filler Device; Injection of device by investigators according to the Instruction For Use (IFU)
Experimental: Group 4; FILLGEL 3	Device: Dermal Filler Device; Injection of device by investigators according to the Instruction For Use (IFU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance - GAIS Investigator	Proportion of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.	6 months, 12 months
Patients Safety	Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication.	Immediatly after injection (D0), 1 month, 6 months, 12 months
Subject Satisfaction - GAIS Subject	Proportion of responders (subjects with a GAIS="improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.	1, 6, 12 months
Injector Satisfaction	Distribution of each item of the questionnaire answered by the injectors (injector's satisfaction on the injection quality using subjective evaluation questionnaire). The scale is "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied" or "Very satisfied" The percentage of satisfied injectors includes participants that reported being "satisfied" and "very satisfied"	After injection

Collaborators and Investigators

• Sponsor: Kylane Laboratoires
• Collaborators: Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: dermatology; Aesthetic
• Other Study ID Numbers: 22E0978

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No