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

Regen Lab SA31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Wrinkling

Interventions

Regenkit BCT-HA Cellular MatrixDEVICE

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 6 months

Data from ClinicalTrials.gov

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