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

Skin Wrinkling Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832583
• Other study ID #: 2014-A00718-39
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: September 30, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Regen Lab SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Wrinkling

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regen Lab SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the changes of facial apparent overall assessed by FACE-Q scale.	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	No
Secondary	Evaluate the changes of skin elasticity assessed by the Cutometer®	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	No