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

Regen Lab SA0 sites31 target enrollmentDecember 2014

ConditionsSkin Wrinkling

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Wrinkling
Sponsor: Regen Lab SA
Enrollment: 31
Primary Endpoint: Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regen Lab SA

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluate the changes of facial apparent overall assessed by FACE-Q scale.

Time Frame: 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)