Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA 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.

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Key information

Conditions

Skin Wrinkling

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regenkit BCT-HA Cellular Matrix

Device

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.

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)

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

Regen Lab SA

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Jul 14, 2016
Registry last updated: Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed