The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study. Safety endpoint: incidence of adverse events.
The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol. Assessments under this protocol will include ultrasound of in vivo tissue. Safety endpoint: incidence of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
A pre specified amount will be injected in tissue at selected timepoints
Ocean Clinic - Av. Ramon y Cajal 7, 29601
Marbella, Spain
Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 1 - Ultrasound Analyses - Elastosis
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade.
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 1 - Ultrasound Analyses - Microvascular Formation
Microvascular formation assessed by ultrasound at the injection site and reported according to the study-defined category/grade.
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Skin Thickness (mm)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Time frame: 6 months prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Elastosis
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade
Time frame: 6 months prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Microvascular Formation
Microvascular formation assessed by ultrasound at injection site and reported according to the study-defined category/grade.
Time frame: 6 months prior to surgery timepoint(s)
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