N/A N=86 Other

Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Aesthetic Dermatology

Bottom Line

View on ClinicalTrials.gov: NCT06142643 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Performance at 1 Month Investigator Overall VISCOL Range — 77 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dermal Filler Device (Device)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Kylane Laboratoires
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Performance at 1 Month Investigator Overall VISCOL Range	77	<0.0001 sig
SECONDARY Performance at 4 Months Investigator Overall VISCOL Range	69	<0.0001 sig
SECONDARY Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range	85; 78	—
SECONDARY Performance at 1 & 4 Months Subject Overall VISCOL Range	69; 62	—
SECONDARY Percentage of Indications With Response: GAIS Subject Overall VISCOL Range	80; 70	—
SECONDARY Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range	73; 64	—
SECONDARY Injector Satisfaction Questionnaire Viscol	100; 100; 100; 100; 100; 51.7	—
SECONDARY Subject Satisfaction Questionnaire Viscol	64.1; 63.6; 76.2; 68.2; 51.6; 59.1	—
SECONDARY Percentage of Participants Experiencing Adverse Events	26; 6; 4; 0; 0; 0	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06142643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.