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

Not Applicable

Completed

• Conditions: Keloid
• Interventions: Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT

• Registration Number: NCT02922972
• Lead Sponsor: Regen Lab SA

Brief Summary

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.

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Autologous Platelet Rich Plasma obtained with RegenKit®-BCT	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.	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 Outcome Measures

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