Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT

Overview

The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars refractory to conventional treatments. Fifteen patients were included and received three PRP injection sessions with a one-month interval. The outcomes were assessed at baseline (before treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by reported adverse event analysis.

Full Title of Study: “Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

Detailed Description

To evaluate the efficacy and the safety of platelet rich plasma in the treatment of keloid scars. This prospective, comparative study (before-after treatment) included 15 patients with keloid scars refractory to conventional treatment (corticoids, surgery, cryotherapy). The primary outcome was the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. Secondary outcomes were the Vancouver scar scale and pruritus severity scored at 3, 6, 12 and 24 months post treatment vs baseline.

Interventions

  • Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
    • After complete resection of the keloid scar, the first injection was administered before closure into the lesion resection bed and edges. Three additional injections were administered with a one-month interval.

Arms, Groups and Cohorts

  • Experimental: Platelet Rich Plasma
    • Interventions: Four injections of PRP: The first injection of A-PRP after complete resection of the keloid scar,Three additional injections were administered with a one-month interval.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
    • Time Frame: 24 months
    • The efficacy of autologous platelet concentrate obtained with RegenKit®-BCT was assessed based on the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.

Secondary Measures

  • Evaluation of the scar using Vancouver scale.
    • Time Frame: 24 months
    • The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.
  • prirutis severity
    • Time Frame: 24 months
    • The efficacy of the treatment was also assessed on the Pruritus severity
  • Pain assessment
    • Time Frame: 3 months
    • pain assessment during injections were also scored using the VAS.
  • patient satisfaction
    • Time Frame: 24 months
    • Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS
  • Adverse events
    • Time Frame: 24 months
    • Adverse events were reported.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with keloid scars refractory to conventional treatments. The indication of PRP injection was based on the absence of response to corticosteroids alone or in combination with surgery after 4 sessions of infiltration and/or absence of response to other therapies. Exclusion Criteria:

  • Patients younger than 18 years – Pregnancy or breastfeeding – Patients suffering from anemia – patients with active skin disorder infection including active hepatitis or human infection virus infection – Auto-immune disease such as Hashimoto, rheumatoid arthritis. – Malignancy with or without metastatic disease – Chemotherapy – Anticoagulant therapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regen Lab SA
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.