KeloidNCT02922972
Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
A study testing Autologous Platelet Rich Plasma obtained with RegenKit®-BCT in people with Keloid, run by Regen Lab SA.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
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.
Read the 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.
- Conditions
- Keloid
- Being tested
- Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
- Keywords
- Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich Plasma obtained with RegenKit®-BCTDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
Evaluation of the scar using Vancouver scale.
The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.
Measured: 24 months
prirutis severity
The efficacy of the treatment was also assessed on the Pruritus severity
Measured: 24 months
Pain assessment
pain assessment during injections were also scored using the VAS.
Measured: 3 months
patient satisfaction
Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS
Measured: 24 months
Adverse events
Adverse events were reported.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922972
- Sponsor's protocol ID
- 2014-A00163-44
- Status last verified
- Nov 2019
- First submitted
- 30 Sep 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29762444
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
- ClinicalTrials.gov ID
- NCT02922972
- Acronym / sponsor ID
- 2014-A00163-44
- Conditions
- Keloid
- Keywords
- Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCTInterventions: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet Rich Plasma obtained with RegenKit®-BCTAlso: RegenKit®-BCTAfter 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. | Device | Platelet Rich Plasma |
Primary outcome
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.
5 secondary outcomes
Evaluation of the scar using Vancouver scale.
Time frame: 24 months
prirutis severity
Time frame: 24 months
Pain assessment
Time frame: 3 months
patient satisfaction
Time frame: 24 months
Adverse events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Derived from this study: PubMed 29762444Hersant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet Rich Plasma obtained with RegenKit®-BCT in people with Keloid, run by Regen Lab SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.