Skin AgingSKINMATNCT03529292
Pilot Study to Evaluate the Safety and the Efficacy of the Matrix and Cells Obtained by the AmeaCell® Device and Intended for the Filling of Wrinkles on the Face.
A study testing AmeaCell in people with Skin Aging, run by Symbioken at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- AmeaCell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jul 2018to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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
- Conditions
- Skin Aging
- Being tested
- AmeaCell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmeaCellDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Matrix and Cells obtained by the AmeaCell® device | Experimental | Not described Receives: Device: AmeaCell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the Adverse Event(s)
Adverse events will be investigated and recorded at each visit by the investigator
Measured: 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).
Measured: First 4 weeks after the injection
Secondary outcomes (3)
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
Measured: Change from baseline at month 1, 6 and 12
Depth of the wrinkles by 3D picture
Measured: Change from baseline at month 1, 6 and 12
Global Aesthetic Improvement Scale (GAIS) Evaluation
The GAIS scale ("Global Aesthetic Improvement Scale") is a judgment scale noting the apparent overall aesthetic improvement, in comparison with the aspect observed before the injection (on a photograph taken during the day of inclusion). Rating categories are: "Worse"; "No change"; "Slightly improved", "Much improved"; "Very much improved".
Evaluations are carried out by the investigator but also by the subject himself according to the same criteria.
Measured: Change from baseline at month 1, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start9 Jul 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symbioken
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Cuylits, Principal investigator, Hôpital Erasme, Bruxelles, BELGIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529292
- Sponsor's protocol ID
- SYMB-SAF1701
- Acronym
- SKINMAT
- Status last verified
- Nov 2021
- First submitted
- 4 May 2018
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03529292
- Acronym / sponsor ID
- SKINMAT / SYMB-SAF1701
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SymbiokenIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix and Cells obtained by the AmeaCell® device | Experimental | Device: AmeaCell |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmeaCellLipoaspirate 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. | Device | Matrix and Cells obtained by the AmeaCell® device |
Primary outcome
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
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).
3 secondary outcomes
Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds
Time frame: Change from baseline at month 1, 6 and 12
Depth of the wrinkles by 3D picture
Time frame: Change from baseline at month 1, 6 and 12
Global Aesthetic Improvement Scale (GAIS) Evaluation
Time frame: Change from baseline at month 1, 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Cuylits principal investigator
Hôpital Erasme, Bruxelles, BELGIUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmeaCell in people with Skin Aging, run by Symbioken at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the Adverse Event(s) (time frame: From selection up to 12 months after the injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.