Prospective, Multicentric, Open Label Clinical Investigation to Evaluate Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Prospective, Multicentric, Open Label Clinical Investigation to Evaluate Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. The main questions it aims to answer are:
If the products are safe
- Acceptable local tolerance, with acceptable clinical signs after injection.
If the clinical performance is as intended compared to baseline
Inclusion Criteria:
Healthy Subject
Sex: male or female
Age: more than 18 years
Subject seeking an improvement of her/his face aspect with resorbable filler
Subject having given their free, express, and informed consent
Subject psychologically able to understand the information related to the study, and to give their written informed consent
Subject affiliated to a health social security system
Women of childbearing potential should use a contraceptive method considered effective since at least 12 weeks and throughout the study
Women of childbearing potential must have a negative urinary pregnancy test on D0
Exclusion Criteria:
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 participating to another clinical research or being in an exclusion period for a previous study
In France: subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study
Subject already included in another group of this study
Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face in the 6 previous months
Subject having received mesotherapy products or botulinum toxin in the same area in the 6 previous months
Subject having received resorbable filling product (e.g., hyaluronic acid) injections in the same area in the 12 previous months
Subject having received slowly resorbable filling product (e.g., calcium hydroxyapatite, polycaprolactone, polylactic acid) injections in the same area or resorbable threads in the 24 previous months
Subject having received injections of permanent products in the face (e.g., acrylate polymers, silicone, polytetrafluoroethylene)
Subject having received facial or cervico-facial lifting in the 24 previous months
Subject wearing skin support device (mesh, gold threads, permanent lifting threads) on the face
Subject with uncontrolled and/or recently recovered (<6 months) depression or psychiatric disorders or any other disorder that may pose a health risk to the subject in the study and/or may have an impact on the study assessments
Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, HIV, or other major disease (e.g., systemic fungal infection)
Subject with recurrent porphyria, untreated epilepsy, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism
Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk
Subject with known history of or suffering from autoimmune disease and/or immune deficiency
Subject with current cutaneous inflammatory or infectious processes (e.g., acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or a cancerous or precancerous lesion on the face
Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies, history of granulomatous diseases
Subject with known hypersensitivity to chlorhexidine
Subject having history of allergy or hypersensitivity to one of the components of the tested device, like hyaluronic acid, lidocaine or other amine-type local anaesthetics. polysaccharides of edible mushrooms
Subject predisposed to keloids or hypertrophic scarring
Subject with coagulation and/or homeostasis disorders
Subject with evidence of lymphatic or venous stasis or serious blood disorders
Subject with pigmentation disorders
Subject with history of Streptococcus disease (recurrent sore throats, acute rheumatic fever)
Subjects with congenital methemoglobinemia or receiving concomitant treatment with methaemoglobin-inducing agents
For subject injected in the chin: subject with clinically significant malocclusion (severe overbite), having dentures and/or any device covering the palate that would interfere with visual assessment of the chin area
Subject with tattoos, piercings, facial hairs mole or scar that would interfere with visual assessment on the injected area
Subject with symptoms consistent with COVID-19 or suffering from ongoing symptoms from previous COVID-19 infection
Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, within 1 month prior to injection, and one-month post-injection.
Subject with a treatment that reduces or inhibits hepatic metabolism (cimetidine, beta-blockers, etc..)
Subject having received a vaccine within 21 days prior to injection or planning to do in the 14 days post-injection
Subject having received dental care within 6 weeks prior to the study or planning to have dental care within 6 weeks post-injection
Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk
Subject undergoing a topical (on the face) or systemic treatment:
Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study
Heavy smoker (subject who reports smoking 10 or more cigarettes per day);
Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day)