Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics

Inclusion criteria

• Healthy subject.
• Sex: male and female
• Age: 18 years or older
• Subject seeking an improvement of her/his face aspect using an aesthetic procedure.
• Subject with mild to moderate wrinkles (grade 1, 2 or 3 on the 6-points Lemperle Scales) on at least 2 of the following area:

• Horizontal forehead lines
• Periorbital lines
• Cheek folds
• Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.
• 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 registered with a social security scheme.
• Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.
• Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion criteria

• 1. Subjects who are pregnant, nursing or intend to become pregnant during study participation.

• 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. 4. Subjects that are currently enrolled in another drug or device study. 5. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

• Subjects with a history of allergies or hypersensitivity to any components or ingredients in the device (especially allergy to nickel or gold).

• Subjects with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple and severe allergies.

• Subjects that have any skin pathology or condition including tattooing or scarring that could interfere with the evaluation of the treatment areas.

• Subjects who suffer from rosacea, eczema, psoriasis, atopic dermatitis, sun-burned or broken skin, inflammatory or irritated skin conditions, active cold sores, moderate to severe acne, abscess, herpes, unhealed wound, cancerous or precancerous lesion on the face.or are taking any prescribed medication for their skin or any skin disease.

• 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 predisposed to keloids or hypertrophic scarring. 13. Subjects who have a hemorrhagic (bleeding) disorder or hemostatic (bleeding) dysfunction.

• Subject with pigmentation disorders (vitiligo, melasma,….). 15. Subjects who have had any form of collagen soft tissue treatment within the last 12 months.

• Subject having resorbable filling product (e.g., hyaluronic acid) injections, an ultrasound-based treatment, a dermabrasion, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to study start and a facial surgery in the past 2 years.

• Subject having received injections of permanent (e.g., acrylate polymers, silicone, polytetrafluoroethylene) or semi-permanent filling on the face (L Polylactic acid, Calcium Hydroxyapatite...).

• Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).

• Subjects having received botulinum toxin in the face within the 9 previous months.

• Subject having received mesotherapy products in the face within the 6 previous months.

• Subject having done a superficial or medium peeling or a superficial scrub on the face or having received LED or laser treatment on the face within the 2 previous months.

• Subject having used cosmetic products with alpha hydroxy acids (AHA) in the previous month.

• Subjects who are currently, or within the past 3 months, treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids (including inhaled or insufflated corticosteroids).

• Subjects who are currently, or within the past 3 months, treated with any topical OTC drug or prescription therapy on their face.

• Subjects taking an antithrombotic, antiplatelet or other blood thinning medications in the past 3 months.

• Subject taking food supplement with an effect on skin quality (collagen, DHEA, …) in the 3 previous months.

• Subjects that have received an investigational drug or device within 30 days prior to entering this 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.