Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

NCT06142643 | Completed Results

• 1 other identifier: 23E1077
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aesthetic Dermatology

Keywords

Aesthetic; dermatology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Performance at 4 Months Investigator Overall VISCOL Range

  4 months

• Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range

  1 month & 4 months

• Performance at 1 & 4 Months Subject Overall VISCOL Range

  1 month, 4 months

• Percentage of Indications With Response: GAIS Subject Overall VISCOL Range

  1 month & 4 months

• Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range

  1 month & 4 months

Study Arms (1)

Device under investigation

EXPERIMENTAL

Device: Dermal Filler Device

Interventions

Dermal Filler Device DEVICE

Injection of the device by investigators according to the IFU

Device under investigation

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Subject.
• Sex: male or female.
• Age: between 35 and 70 years.
• Subject seeking an improvement for HA skin quality improvement product.
• Subject with BMI \<30.
• 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 his/her 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 12 weeks and throughout the study

You may not qualify if:

• 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 6.000 euros as compensations for their participation in clinical research in the last 12 months, including their participation in the present study.
• 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

Sponsors & Collaborators

• Kylane Laboratoires: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Kylane Laboratoires

Plan-les-Ouates, 1228, Switzerland

Location

Results Point of Contact

• Title: Basste Hadjab, Sponsor
• Organization: Kylane Laboratoires

compliance@kylane.com

0225889611

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 21, 2023
• Study Start: December 8, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)