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

Keloid Clinical Trial

Official title:

Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922972
• Other study ID #: 2014-A00163-44
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2019
• Source: Regen Lab SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regen Lab SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.	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.	24 months
Secondary	Evaluation of the scar using Vancouver scale.	The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.	24 months
Secondary	prirutis severity	The efficacy of the treatment was also assessed on the Pruritus severity	24 months
Secondary	Pain assessment	pain assessment during injections were also scored using the VAS.	3 months
Secondary	patient satisfaction	Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS	24 months
Secondary	Adverse events	Adverse events were reported.	24 months