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

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ClinicalTrials.gov Identifier: NCT02832583
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Regen Lab SA

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.

Condition or disease Intervention/treatment Phase
Skin Wrinkling Device: Regenkit BCT-HA Cellular Matrix Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regen Lab SA
ClinicalTrials.gov Identifier: NCT02832583     History of Changes
Other Study ID Numbers: 2014-A00718-39
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Regen Lab SA:
PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents