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

RegenLab

Status: Completed

Conditions: Skin Wrinkling

Treatments: Device: Regenkit BCT-HA Cellular Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02832583

2014-A00718-39

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Mesotherapy of PRP-HA into the cheeks

Experimental group

Description:

Three sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval.

Treatment:

Device: Regenkit BCT-HA Cellular Matrix