Pilot Study to Evaluate the Safety and the Efficacy of th... | NCT03529292

NCT03529292

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Matrix and Cells obtained by the AmeaCell® device	Experimental		Device: AmeaCell

Name	Type	Description	Arm Group Labels	Other Names
AmeaCell	Device	Lipoaspirate obtained from liposuction is treated by the AmeaCell® device in order to obtain Matrix and Cells which contains cellular phase and matrix phase. The Matrix ancd Cells are injected in the same patient as facial wrinkles filler.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of the Adverse Event(s)	Adverse events will be investigated and recorded at each visit by the investigator	From selection up to 12 months after the injection
Local tolerance	The subject will record daily the local tolerance in a diary card. Signs of erythema, edema, bruising, discolouration, pain / tenderness, and pruritus will be noted and scored from 0 (none) to 3 (severe).	First 4 weeks after the injection

Secondary Outcomes

Measure	Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds	The Wrinkle Severity Rating Scale (WSRS) is a 5-point reference scale with photographs that classifies deep facial wrinkles (Nasolabial Folds). The grading is performed on both sides to give a reliable and reproducible gradation of the depth of the folds. The grading of the wrinkles is made by the investigator according to the following grades: Grade 1 No visible nasolabial folds; continuous skin line Grade 2 Shallow but visible nasolabial folds with a slight indentation Grade 3 Moderate deep nasolabial folds; visible at normal appearance Grade 4 Very long and deep nasolabial folds; prominent facial feature ;< 2mm visible fold if stretched Grade 5 Extreme deep long nasolabial folds; 2-4mm V shaped fold if stretched

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Man or woman from 18 to 70 years
Subject wishing liposuction
Subject wishing a filling of facial wrinkles for aesthetic purposes
Subject for which it is possible to achieve a puncture of adipose tissue of at least 150ml so that after decantation or centrifugation there remains 100ml of adipose tissue
Facial wrinkles that can be treated with the Matrix and Cells volume of approximately 12ml
Grade of wrinkles at level 2 minimum of the nasolabial fold according to the WSRS scale
Free, informed and written consent
Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

Pregnant or breastfeeding woman or planning to be pregnant
Woman of childbearing age without effective contraceptive
Subject having a filling of facial wrinkles with hyaluronic acid or by a method of lipofilling (injection of adipose tissue) in the 12 months prior to the enrollment
Subject who has undergone treatment of facial wrinkles by injection of botulinum toxin, by mesotherapy or cosmetic procedure (laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative procedures) within 12 months at least prior to enrolment or subject who is planning this type of procedure during the study
Subject who has received semi-permanent dermal fillers or permanent facial implants or who is planning to do this type of implant during the study
Subject having history of formation of hypertrophic scars or keloids
Subject having a skin disease or skin inflammation (e.g. acne, herpes, eczema, psoriasis, sclerosis) at the site to be treated or elsewhere on the body if suspected of spreading on the site to be treated
Subject with allergic contact dermatitis or a history of allergic contact dermatitis or a family history of allergic contact dermatitis
Presence of tattoo and / or scar in the treatment area that, in the opinion of the investigator, could interfere with the evaluation of the study
Diabetes (type I or type II)
Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) seropositivity
Subject under anti-HIV treatment
Autoimmune disease
Immunodepression
History of phlebitis or pulmonary embolism
Major pathology involving the renal, hepatic, cardiovascular, immune and / or nervous system
Cancerous lesion on the face
Any other diseases that could, in the opinion of the investigator, be clinically significant and make the subject inappropriate for the study, alter the results of the study or increase the risk for the subject
Known hypersensitivity to cobalt
Known hypersensitivity to collagenase
Known or suspected allergy to lidocaine or any other amide anesthetic
History of known severe allergies (anaphylaxis, angioedema) for a product used in the study
Any contraindication to lipofilling surgery
Active smoking or subject who stopped smoking less than one month before the intervention
Radiotherapy treatment at the head and neck region.
Chemotherapy treatment
Treatment with anticoagulant or Nonsteroidal anti-inflammatory drug (NSAID) or any other substance known to increase clotting time during the 2 weeks prior to enrollment
Corticosteroids in the 6 weeks prior to enrollment
Subject having a metal-metal hip prosthesis
Subject under lidocaine or structurally related local anesthetic (e.g. bupivacaine) within 24 hours prior to enrollment
Subject having undergone general anesthesia for less than 8 days
Treatment with an oral or topical retinoid in the month prior to enrollment
Subject having a history of drug or alcohol addiction in the 12 months prior to enrollment
Participation in another research including an exclusion period still in progress at the time of enrollment
Person placed under guardianship or curatorship or under the protection of justice