Pilot Study to Evaluate the Safety and the Efficacy of the Modified Matrix Obtained by the AmeaCell® Device and Intended for the Filling of Wrinkles on the Face. (SKINMAT)
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|ClinicalTrials.gov Identifier: NCT03529292|
Recruitment Status : Unknown
Verified September 2018 by Symbioken.
Recruitment status was: Recruiting
First Posted : May 18, 2018
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging||Device: AmeaCell||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate the Safety and the Efficacy of the Filling Using the Modified Matrix, Obtained by the AmeaCell® Device From Autologous Adipose Tissue and Intended for the Filling of Wrinkles on the Face.|
|Actual Study Start Date :||July 9, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
|Experimental: Modified matrix obtained by the AmeaCell® device||
Lipoaspirate obtained from liposuction is treated by the AmeaCell® device in order to obtain de modified matrix which contains cellular phase and matrix phase. The modified matrix is injected in the same patient as facial wrinkles filler.
- 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).
- Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds [ Time Frame: Change from baseline at month 1, 6 and 12 ]
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
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529292
|Contact: Véronique SANTRAN||+33(0)5 31 21 68 firstname.lastname@example.org|
|Contact: Nicolas Cuylits +3225554550 Nicolas.Cuylits@erasme.ulb.ac.be|
|Principal Investigator:||Dr Cuylits||Hôpital Erasme, Bruxelles, BELGIUM|