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

September 30, 2016 updated by: Regen Lab SA

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mesotherapy of PRP-HA into the cheeks
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the changes of skin elasticity assessed by the Cutometer®
Time Frame: 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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regen Lab SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-A00718-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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