Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA in Aesthetic Medicine

Study Overview
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Brief Summary
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The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.

Official Title
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Efficacy of the Use of Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With regenKit BCT-HA Cellular Matrix for Skin in Aesthetic Medicine

Conditions
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Skin Wrinkling

Intervention / Treatment
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* Device: Regenkit BCT-HA Cellular Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 40 years with chronological aging Completed informed consent form Exclusion Criteria: Pregnancy or breastfeeding Patients younger than 40 years Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start, patients with known hypersensitivity to HA, patients with eczema flare-up, patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection. Dermatological diseases affecting the face Auto-immune disease such as Hashimoto, rheumatoid arthritis. Malignancy with or without metastatic disease Chemotherapy Anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesotherapy of PRP-HA into the cheeks<br>Three sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval. | Device: Regenkit BCT-HA Cellular Matrix<br>* To assess the efficacy of PRP-HA on skin rejuvenation, thirty one patients with chronological aging including wrinkles, dull and dry skin with loss of elasticity and firmness. The patients received three PRP-AH injection sessions 4 weeks apart into the cheeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes of facial apparent overall assessed by FACE-Q scale. | Evaluate changes in facial apparent assessed by FACE-Q scale after 6 month of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes of skin elasticity assessed by the Cutometer® | Evaluate changes in skin elasticity assessed by the Cutometer® after 6 months of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation