Aesthetic DermatologyNCT06142578
Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices
A study testing Dermal Filler Device in people with Aesthetic Dermatology, run by Kylane Laboratoires at 1 site in Switzerland.
Trial summary
The study aims to confirm the safety and effectiveness of FILLGEL devices Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Dermatology
- What is being tested?
- Dermal Filler Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Aesthetic Dermatology
- Being tested
- Dermal Filler Device
- Keywords
- Aesthetic, dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal Filler DeviceDevice
Injection of device by investigators according to the Instruction For Use (IFU)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | FILLGEL 0 Receives: Device: Dermal Filler Device |
| Group 2 | Experimental | FILLGEL 1 Receives: Device: Dermal Filler Device |
| Group 3 | Experimental | FILLGEL 2 Receives: Device: Dermal Filler Device |
| Group 4 | Experimental | FILLGEL 3 Receives: Device: Dermal Filler Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 1 month
Secondary outcomes (4)
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%.
Measured: 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.
Measured: 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%.
Measured: 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"
Measured: After injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start14 Nov 2022
- Primary completion12 Jan 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aesthetic DermatologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kylane Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142578
- Sponsor's protocol ID
- 22E0978
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2023
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Clinical Evaluation of the Range of Injectable Medical Devices Fillgel in Facial Aesthetic Treatment
- ClinicalTrials.gov ID
- NCT06142578
- Acronym / sponsor ID
- 22E0978
- Conditions
- Aesthetic Dermatology
- Keywords
- Aesthetic, dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kylane LaboratoiresIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to confirm the safety and effectiveness of FILLGEL devices
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Dermal Filler DeviceFILLGEL 0 |
| Group 2 | Experimental | Device: Dermal Filler DeviceFILLGEL 1 |
| Group 3 | Experimental | Device: Dermal Filler DeviceFILLGEL 2 |
| Group 4 | Experimental | Device: Dermal Filler DeviceFILLGEL 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an improvement of lip volume;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermal Filler DeviceInjection of device by investigators according to the Instruction For Use (IFU) | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Performance
Time frame: 1 month
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%.
4 secondary outcomes
Performance - GAIS Investigator
Time frame: 6 months, 12 months
Patients Safety
Time frame: Immediatly after injection (D0), 1 month, 6 months, 12 months
Subject Satisfaction - GAIS Subject
Time frame: 1, 6, 12 months
Injector Satisfaction
Time frame: After injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal Filler Device in people with Aesthetic Dermatology, run by Kylane Laboratoires at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.