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

Not Applicable

Completed

• Conditions: Skin Wrinkling
• Interventions: Device: Regenkit BCT-HA Cellular Matrix

• Registration Number: NCT02832583
• Lead Sponsor: Regen Lab SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesotherapy of PRP-HA into the cheeks	Regenkit BCT-HA Cellular Matrix	Three sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval.

Primary Outcome Measures

Name	Time	Method
Evaluate the changes of facial apparent overall assessed by FACE-Q scale.	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Evaluate the changes of skin elasticity assessed by the Cutometer®	6 months	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).