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

NCT ID: NCT02832583

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Regenkit BCT-HA Cellular Matrix

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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
• Anticoagulant therapy

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regen Lab SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 28807118 (View on PubMed)

Other Identifiers

2014-A00718-39

Identifier Type: -

Identifier Source: org_study_id