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

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ClinicalTrials.gov Identifier: NCT02922972
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Keloid Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.
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.
Other Name: RegenKit®-BCT




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regen Lab SA
ClinicalTrials.gov Identifier: NCT02922972    
Other Study ID Numbers: 2014-A00163-44
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Regen Lab SA:
Keloid scar
Wound healing
Platelet-Rich Plasma
RegenLab
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes