NCT02922972

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

September 30, 2016

Last Update Submit

November 13, 2019

Conditions

Keloid

Keywords

Keloid scarWound healingPlatelet-Rich PlasmaRegenLab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Evaluation of the scar using Vancouver scale.

    24 months

  • prirutis severity

    24 months

  • Pain assessment

    3 months

  • patient satisfaction

    24 months

  • Adverse events

    24 months

Study Arms (1)

Platelet Rich Plasma

EXPERIMENTAL

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

Interventions

Autologous Platelet Rich Plasma obtained with RegenKit®-BCTDEVICE

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.

Also known as: RegenKit®-BCT
Platelet Rich Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hersant B, SidAhmed-Mezi M, Picard F, Hermeziu O, Rodriguez AM, Ezzedine K, Meningaud JP. Efficacy of Autologous Platelet Concentrates as Adjuvant Therapy to Surgical Excision in the Treatment of Keloid Scars Refractory to Conventional Treatments: A Pilot Prospective Study. Ann Plast Surg. 2018 Aug;81(2):170-175. doi: 10.1097/SAP.0000000000001448.

    PMID: 29762444DERIVED

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 4, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share