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Completed

NCT Number: NCT02922972

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

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.

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Key information

Conditions

Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet Rich Plasma obtained with RegenKit®-BCT

Device

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.

Other names: RegenKit®-BCT

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. prirutis severity

    Time frame: 24 months

    The efficacy of the treatment was also assessed on the Pruritus severity

  3. Pain assessment

    Time frame: 3 months

    pain assessment during injections were also scored using the VAS.

  4. patient satisfaction

    Time frame: 24 months

    Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS

  5. Adverse events

    Time frame: 24 months

    Adverse events were reported.

Sponsors and collaborators

Lead sponsor

Regen Lab SA

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2016
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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