NCT06142578

Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices

Completed NA Results posted Last updated 25 April 2025

What this trial tests

NA trial testing Dermal Filler Device in Aesthetic Dermatology in 68 participants. Completed in 31 January 2024.

Timeline

14 November 2022

Primary endpoint
12 January 2023

31 January 2024

Quick facts

Lead sponsor	Kylane Laboratoires
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	68
Start date	14 November 2022
Primary completion	12 January 2023
Estimated completion	31 January 2024
Sites	1 location across Switzerland

Drugs / interventions tested

• Dermal Filler Device

Conditions studied

• Aesthetic Dermatology — all drugs for Aesthetic Dermatology →

Sponsor

Kylane Laboratoires

Who can join

Adults 18 to 65, any sex, with Aesthetic Dermatology. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Performance Primary · 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%.

Group	Value	95% CI
All Groups	97.6

Performance - GAIS Investigator Secondary · 6 months, 12 months

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%.

At 6 months

Group	Value	95% CI
All Groups	94
Group 1	82.4
Group 2	95.6
Group 3	100
Group 4	96.4

At 12 months

Group	Value	95% CI
All Groups	88
Group 1	76.5
Group 2	95.6
Group 3	94.1
Group 4	86.8

Patients Safety Secondary · Immediatly after injection (D0), 1 month, 6 months, 12 months

Proportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication.

Immediatly after injection (D0)

Group	Value	95% CI
Group 1	88
Group 2	100
Group 3	47
Group 4	47

1 month

Group	Value	95% CI
Group 1	24
Group 2	13
Group 3	6
Group 4	6

6 months

Group	Value	95% CI
Group 1	0
Group 2	13
Group 3	0
Group 4	0

12 months

Group	Value	95% CI
Group 1	6
Group 2	0
Group 3	0
Group 4	0

Subject Satisfaction - GAIS Subject Secondary · 1, 6, 12 months

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%.

At 1 month

Group	Value	95% CI
All Groups	90.4
Group 1	94.1
Group 2	100
Group 3	100
Group 4	75.3

At 6 months

Group	Value	95% CI
All Groups	81.9
Group 1	64.7
Group 2	92.9
Group 3	88.2
Group 4	81.2

At 12 months

Group	Value	95% CI
All Groups	79.5
Group 1	76.4
Group 2	92.9
Group 3	88.1
Group 4	63.3

Injector Satisfaction Secondary · After injection

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"

Easiness of injection

Group	Value	95% CI
Group 1	100
Group 2	100
Group 3	100
Group 4	100

Easiness of product positionning

Group	Value	95% CI
Group 1	100
Group 2	100
Group 3	100
Group 4	100

Immediate results

Group	Value	95% CI
Group 1	100
Group 2	100
Group 3	100
Group 4	100

Result after massage

Group	Value	95% CI
Group 1	100
Group 2	100
Group 3	100
Group 4	100

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Device Under Investigation (Total of Groups)

Serious: 2/68 (3%)

Deaths: 0/68

Group 1

Serious: 1/17 (6%)

Deaths: 0/17

Group 2

Serious: 1/17 (6%)

Deaths: 0/17

Group 3

Serious: 0/17 (0%)

Deaths: 0/17

Group 4

Serious: 0/17 (0%)

Deaths: 0/17

Serious adverse events (2 terms)

Reaction	System	Device Under Investigation…	Group 1	Group 2	Group 3	Group 4
spleen cyst	General disorders	—	—	—	—	—
strangulated femoral hernia	General disorders	—	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Device Under Investigation…	Group 1	Group 2	Group 3	Group 4
AE not device related	Surgical and medical procedures	—	—	—	—	—
ADE	Surgical and medical procedures	—	—	—	—	—

Most-reported serious reactions: spleen cyst, strangulated femoral hernia.

Data from ClinicalTrials.gov NCT06142578 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.