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

NCT02832583 | Completed

• 1 other identifier: 2014-A00718-39
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Wrinkling

Keywords

PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluate the changes of skin elasticity assessed by the Cutometer®

  6 months

Study Arms (1)

Mesotherapy of PRP-HA into the cheeks

EXPERIMENTAL

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

Interventions

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.

Mesotherapy of PRP-HA into the cheeks

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 40 years with chronological aging
• Completed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Regen Lab SA: lead

Related Publications (1)

• Hersant B, SidAhmed-Mezi M, Niddam J, La Padula S, Noel W, Ezzedine K, Rodriguez AM, Meningaud JP. Efficacy of autologous platelet-rich plasma combined with hyaluronic acid on skin facial rejuvenation: A prospective study. J Am Acad Dermatol. 2017 Sep;77(3):584-586. doi: 10.1016/j.jaad.2017.05.022. No abstract available.

  PMID: 28807118 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 14, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share