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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832583
First Posted: July 14, 2016
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regen Lab SA
  Purpose
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 Intervention
Skin Wrinkling Device: Regenkit BCT-HA Cellular Matrix

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Regen Lab SA:

Primary Outcome Measures:
  • 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:
  • 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).


Enrollment: 31
Study Start Date: December 2014
Study Completion Date: June 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: July 5, 2016
First Posted: July 14, 2016
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