Pilot Study to Evaluate the Safety and the Efficacy of the Filling Using the Matrix and Cells, Obtained by the AmeaCell® Device From Autologous Adipose Tissue and Intended for the Filling of Wrinkles on the Face.

Symbioken1 site in 1 country23 target enrollmentJuly 9, 2018

ConditionsSkin Aging

Overview

Phase: N/A
Intervention: Not specified
Conditions: Skin Aging
Sponsor: Symbioken
Enrollment: 23
Locations: 1
Primary Endpoint: Local tolerance
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face.

Detailed Description

The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face. This is a mono-center, pilot study in 24 subjects

Registry

clinicaltrials.gov

Start Date

July 9, 2018

End Date

February 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Symbioken

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Local tolerance

Time Frame: First 4 weeks after the injection

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).

Incidence of the Adverse Event(s)

Time Frame: From selection up to 12 months after the injection

Adverse events will be investigated and recorded at each visit by the investigator

Secondary Outcomes

Depth of the wrinkles by 3D picture(Change from baseline at month 1, 6 and 12)
Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds(Change from baseline at month 1, 6 and 12)
Global Aesthetic Improvement Scale (GAIS) Evaluation(Change from baseline at month 1, 6 and 12)