Evaluation of Performance and Safety of KIO015 in Face Tissue Filling

Inclusion criteria

• Subject with signs of cutaneous ageing on the face according to investigator's judgment.
• Subject with dehydrated skin on the face (value < 60 A.U with Corneometer®).
• Subject having given freely and expressly his informed consent.
• Subject, psychologically able to understand the study related information and to give a written informed consent.
• Subject affiliated to a health social security system.
• Female of childbearing potential must use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
• Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion criteria

In terms of population

• Pregnant or nursing woman or planning a pregnancy during the study.
• Woman with menopause from less than 1 year or in perimenopause, without hormonal treatment.
• 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 research on human beings or being in an exclusion period for a previous study.
• Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study.
• Subject suffering from dysmorphophobia or having an unreasonable expectation about the treatment results.
• Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
• Subject with a tattoo, a scar, moles or too many hairs or anything on the face which may interfere with the study at the investigator appreciation.
• Subject having resorbable filling product (e.g., hyaluronic acid) injections, a laser treatment, an ultrasound-based treatment a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to study start.
• Subjects having received botulinum toxin in the face within the 6 previous months.
• Subject having received mesotherapy products in the face within the 3 previous months.
• Subject having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.
• Subject using cosmetic products with alpha hydroxy acids (AHA).
• Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).
• Subject having received injections of permanent (e.g., acrylate polymers, silicone, polytetrafluoroethylene) or semi-permanent filling on the face.
• Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

In terms of associated pathology

• Subject with ongoing and/or 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, tumor, HIV, or other major disease (e.g., systemic fungal infection).
• Subject with recurrent porphyria, 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.
• Subject having history of allergy or hypersensitivity to one of the components of the tested device
• Subject having history of hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of amide type or one of the excipients of EMLA® 5% cream.
• Subject having history of hypersensitivity to chlorhexidine (or similar product) or one of the excipients of alcoholic chlorhexidine 0.5%.
• Subject predisposed to keloids or hypertrophic scarring.
• Subject with coagulation and/or homeostasis disorders.
• Subject with pigmentation disorders. Related to previous or ongoing treatment
• Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study
• 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:

• anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
• immunosuppressors and/or corticoids during the 4 previous weeks and during the study;
• retinoids during the 6 previous months and during the study