Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment

Evaluation of safety and performance of HA based injectable device for skin quality improvement

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 device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.

The secondary objectives of the study are to collect data on:

• the effectiveness four months (M4) after treatment.
• the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
• subject's satisfaction and subject's opinion on aesthetic improvement.
• the injector's satisfaction on the injection quality.
• the safety using clinical evaluation of the Injection Site Reactions (ISR).

• Study Type: Interventional
• Enrollment (Actual): 86
• 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 35 and 70 years.
4. Subject seeking an improvement for HA skin quality improvement product.
5. Subject with BMI <30.
6. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
7. Subject having given his/her free, express, and informed consent.
8. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
9. Subject registered with a social security scheme.
10. Women of childbearing potential should use a contraceptive method considered effective since at least 12 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 6.000 euros as compensations for their participation in clinical research 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device under investigation	Device: Dermal Filler Device; Injection of the device by investigators according to the IFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance at 1 Month Investigator Overall VISCOL Range	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%.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance at 4 Months Investigator Overall VISCOL Range	Percentage of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole VISCOL range.	4 months
Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range	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.	1 month & 4 months
Performance at 1 & 4 Months Subject Overall VISCOL Range	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%	1 month, 4 months
Percentage of Indications With Response: GAIS Subject Overall VISCOL Range	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.	1 month & 4 months
Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range	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.	1 month & 4 months
Injector Satisfaction Questionnaire Viscol	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".	D0 (Immediatly after injection)
Subject Satisfaction Questionnaire Viscol	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".	1 month, 4 months
Percentage of Participants Experiencing Adverse Events	Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE)	6 months

Collaborators and Investigators

• Sponsor: Kylane Laboratoires
• Collaborators: Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 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 (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: dermatology; Aesthetic
• Other Study ID Numbers: 23E1077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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