Clinical trial NCT02922972: Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
Official title: Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keloid
Keywords: Keloid scar
Wound healing
Platelet-Rich Plasma
RegenLab
Lead sponsor: Regen Lab SA
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
timeFrame: 24 months
Secondary outcomes:
measure: Evaluation of the scar using Vancouver scale.
timeFrame: 24 months
measure: prirutis severity
timeFrame: 24 months
measure: Pain assessment
timeFrame: 3 months
measure: patient satisfaction
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.