Trial Outcomes & Findings for Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol (NCT NCT06142643)

NCT ID: NCT06142643

Last Updated: 2025-08-27

Results Overview

Primary endpoint was the percentage 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 GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-08-27

Participant Flow

Unit of analysis: Indication

Participant milestones

Measure	Viscol Face Dermal Filler Device: Injection of the device by investigators according to the IFU in Face area	Viscol Body Dermal Filler Device: Injection of the device by investigators according to the IFU in Body area
Overall Study STARTED	64 64	22 31
Overall Study COMPLETED	64 64	22 31
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Viscol Face n=64 Participants Injection of the device by investigators according to the IFU in the Face area	Viscol Body n=22 Participants Injection of the device by investigators according to the IFU in the Body area	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=64 Participants	0 Participants n=22 Participants	0 Participants n=86 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=64 Participants	22 Participants n=22 Participants	86 Participants n=86 Participants
Age, Categorical >=65 years	0 Participants n=64 Participants	0 Participants n=22 Participants	0 Participants n=86 Participants
Age, Continuous	53 years n=64 Participants	57 years n=22 Participants	54 years n=86 Participants
Sex: Female, Male Female	55 Participants n=64 Participants	21 Participants n=22 Participants	76 Participants n=86 Participants
Sex: Female, Male Male	9 Participants n=64 Participants	1 Participants n=22 Participants	10 Participants n=86 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	64 Participants n=64 Participants	22 Participants n=22 Participants	86 Participants n=86 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Primary endpoint was the percentage of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications

Primary endpoint was the percentage 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 GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%.

Outcome measures

Measure	Viscol Face and Body n=86 Participants All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Performance at 1 Month Investigator Overall VISCOL Range	77 Participants	—

SECONDARY outcome

Timeframe: 4 months

Population: 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation.

Percentage of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole VISCOL range.

Outcome measures

Measure	Viscol Face and Body n=85 Participants All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Performance at 4 Months Investigator Overall VISCOL Range	69 Participants	—

SECONDARY outcome

Timeframe: 1 month & 4 months

Population: 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. Responder rate for the whole indication (N=95 indications) of VISCOL range at M1 and M4.

Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS investigator (N=95 indications).

Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by an independent investigator.

Outcome measures

Measure	Viscol Face and Body n=95 Indications All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range At 1 month	85 percentage of indications	—
Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range At 4 months	78 percentage of indications	—

SECONDARY outcome

Timeframe: 1 month, 4 months

Percentage of responders for the whole VISCOL range as assessed by the subject. This percentage of responders was compared to a theoretical proportion of 60%

Outcome measures

Measure	Viscol Face and Body n=86 Participants All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Performance at 1 & 4 Months Subject Overall VISCOL Range 1 month	69 Participants	—
Performance at 1 & 4 Months Subject Overall VISCOL Range 4 months	62 Participants	—

SECONDARY outcome

Timeframe: 1 month & 4 months

Population: 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation. Responder rate for the whole indication (N=95 indications) of VISCOL range at M1 and M4

Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS subject (N=95 indications) Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by the subject.

Outcome measures

Measure	Viscol Face and Body n=95 Indication All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Percentage of Indications With Response: GAIS Subject Overall VISCOL Range At 1 month	80 percentage of indications	—
Percentage of Indications With Response: GAIS Subject Overall VISCOL Range At 4 months	70 percentage of indications	—

SECONDARY outcome

Timeframe: 1 month & 4 months

Population: Responder rate for the whole VISCOL range by indication (N=95 indications) at M1 and M4- GAIS combined score (investigator and subjects). 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation.

Responder rate for the whole VISCOL range by indication at M1 and M4- GAIS combined score (investigator and subjects) (N=95 indications).

It represents the percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range by indication as assessed by the subject as well as by the investigator.

Outcome measures

Measure	Viscol Face and Body n=95 Indications All study participants	Viscol Body Injection of the device by investigators according to the IFU in the Body area
Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range At 1 month	73 percentage of responders	—
Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range At 4 months	64 percentage of responders	—

SECONDARY outcome

Timeframe: D0 (Immediatly after injection)

Distribution of each item of the questionnaire answered by the injectors. For each item of the injector questionnaire, the percentage of answers "very satisfied" and satisfied were computed as "Satisfied" and the percentage of answers "Neither satisfied" ,or "dissatisfied", "dissatisfied" and "very dissatisfied" were computed as Dissatisfied.

The measure reported is the percentage of participants who were "Satisfied".

Outcome measures

Measure	Viscol Face and Body n=64 Participants All study participants	Viscol Body n=22 Participants Injection of the device by investigators according to the IFU in the Body area
Injector Satisfaction Questionnaire Viscol Ease of removal of the tip-cap	100 percentage of participants	100 percentage of participants
Injector Satisfaction Questionnaire Viscol Ease of needle/cannula assembly with the syringe	100 percentage of participants	100 percentage of participants
Injector Satisfaction Questionnaire Viscol Ease of injection (including extrusion force control)	100 percentage of participants	51.7 percentage of participants
Injector Satisfaction Questionnaire Viscol Handling comfort	100 percentage of participants	100 percentage of participants
Injector Satisfaction Questionnaire Viscol Ease of product positioning	100 percentage of participants	100 percentage of participants
Injector Satisfaction Questionnaire Viscol Immediate result	100 percentage of participants	96.5 percentage of participants
Injector Satisfaction Questionnaire Viscol Result after massage	96.9 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: 1 month, 4 months

Population: 1 subject missed the 4 month visit. But come back for the end of the study. This is included in deviations, and has been assessed as minor deviation.

Distribution of each item of the questionnaire answered by the subjects injected with Viscol. For each item of the subject questionnaire, the percentage of answers "totally agree" and "agree" were computed as "Agree" and the percentage of answers "Neither agree and disagree",or "disagree" and "totally disagree" and "very dissatisfied" were computed as "Disagree".

The measure reported is the percentage of participants who "Agree".

Outcome measures

Measure	Viscol Face and Body n=64 Participants All study participants	Viscol Body n=22 Participants Injection of the device by investigators according to the IFU in the Body area
Subject Satisfaction Questionnaire Viscol Improvement of skin elasticity/pliability at 1 month	76.2 percentage of subjects	68.2 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin laxity at 1 month	51.6 percentage of subjects	59.1 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin hydration at 1 month	70.3 percentage of subjects	63.6 percentage of subjects
Subject Satisfaction Questionnaire Viscol Contour remodelled and more defined at 1 month	54.7 percentage of subjects	31.8 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin hydration at 4 months	73 percentage of subjects	68.2 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin roughness at 4 months	65.1 percentage of subjects	54.5 percentage of subjects
Subject Satisfaction Questionnaire Viscol Decrease of skin fine lines at 4 months	61.9 percentage of subjects	40.9 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin roughness at 1 month	53.1 percentage of subjects	47.6 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin smoothness at 1 month	68.8 percentage of subjects	63.6 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin firmness at 1 month	64.1 percentage of subjects	63.6 percentage of subjects
Subject Satisfaction Questionnaire Viscol Lifting effect at 1 month	57.1 percentage of subjects	50 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement of skin radiance at 1 month	68.8 percentage of subjects	NA percentage of subjects This question has not been asked to subject for Viscol Body, it is not relevant
Subject Satisfaction Questionnaire Viscol Decrease of skin fine lines at 1 month	65.6 percentage of subjects	59.1 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement of the aspect of skin pores at 1 month	67.2 percentage of subjects	50 percentage of subjects
Subject Satisfaction Questionnaire Viscol I am satisfied with the result obtained at 1 month	79.7 percentage of subjects	68.2 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin firmness at 4 months	68.3 percentage of subjects	68.2 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement of skin elasticity/pliability at 4 months	68.3 percentage of subjects	68.2 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin laxity at 4 months	49.2 percentage of subjects	54.5 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement in skin smoothness at 4 months	74.6 percentage of subjects	57.1 percentage of subjects
Subject Satisfaction Questionnaire Viscol Contour remodelled and more defined Contour remodelled and more defined at 4 months	47.6 percentage of subjects	27.3 percentage of subjects
Subject Satisfaction Questionnaire Viscol Lifting effect at 4 months	54 percentage of subjects	50 percentage of subjects
Subject Satisfaction Questionnaire Viscol Improvement of skin radiance at 4 months	69.8 percentage of subjects	NA percentage of subjects This question has not been asked to subject for Viscol Body, it is not relevant
Subject Satisfaction Questionnaire Viscol Improvement of the aspect of skin pores at 4 months	69.8 percentage of subjects	36.4 percentage of subjects
Subject Satisfaction Questionnaire Viscol I am satisfied with the result obtained I am satisfied with the result obtained at 4 months	68.3 percentage of subjects	38.2 percentage of subjects

SECONDARY outcome

Timeframe: 6 months

Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE)

Outcome measures

Measure	Viscol Face and Body n=64 Participants All study participants	Viscol Body n=22 Participants Injection of the device by investigators according to the IFU in the Body area
Percentage of Participants Experiencing Adverse Events At least one AE	26 Participants	6 Participants
Percentage of Participants Experiencing Adverse Events At least one ADE	4 Participants	0 Participants
Percentage of Participants Experiencing Adverse Events At least one SAE	0 Participants	0 Participants

Adverse Events

Viscol Face

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Viscol Body

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Viscol Face n=64 participants at risk Dermal Filler Device: Injection of the device by investigators according to the IFU in face area	Viscol Body n=22 participants at risk Dermal Filler Device: Injection of the device by investigators according to the IFU in body area
Surgical and medical procedures Side effect	40.6% 26/64 • Number of events 55 • 6 months	27.3% 6/22 • Number of events 13 • 6 months

Additional Information

Basste Hadjab, Sponsor

Kylane Laboratoires

Phone: 0225889611

Email: compliance@kylane.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER