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Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris

Primary Purpose

Platelet-Rich Plasma, Acne Vulgaris

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRP
Chemical peeling (Salycilic acid)
Chemical peeling (Jessener's solution)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet-Rich Plasma

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with active acne vulgaris lesions (inflammatory and non-inflammatory).
  • Age range from 14 to 40 years.
  • Patients with any topical and systemic treatments will undergo wash out period of one month.

Exclusion Criteria:

  • Patients with herpes labials, or bacterial infection; warts on the face, actinic keratosis, or skin cancer or allergy to medications.
  • Systemic retinoids intake in the previous 6 months
  • History of keloidal scarring.
  • Patients on anticoagulant therapy or aspirin or have a coagulation issue,
  • Patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
  • Pregnant women
  • Immunocompromised patients
  • Patients with medical diseases like diabetes mellitus, epilepsy or malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    PRP

    Chemical peeling (Salycilic acid)

    Chemical peeling (Jessenr's solution)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cure rate
    Assess cure rate of PRP and Chemical peeling agents in treatment of Aactive Acne Vulgaris in 3 months duration and compare efficacy of all measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 28, 2019
    Last Updated
    March 2, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03859843
    Brief Title
    Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris
    Official Title
    Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 10, 2020 (Anticipated)
    Primary Completion Date
    January 10, 2021 (Anticipated)
    Study Completion Date
    May 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial
    Detailed Description
    Acne vulgaris is one of the most common chronic skin diseases worldwide. The condition usually starts in adolescence, peaks at the ages of 14 to 19 years and frequently resolves by mid-twenties. Acne is characterized by seborrhea, formation of open and closed comedones, erythematous papules and pustules and in more severe cases present with nodules, deep pustules and pseudo cysts, in many cases a degree of scarring will ensue. Its pathophysiology includes hyperseborrhoea, abnormal follicular keratinization and Propionibacterium acnes proliferation in the pilosebaceous unit. Acne is a significant clinical problem with sever social, psychological, and emotional implications. A mainly genetically determined host response pattern combined with bacterial ''triggering'' is generally accepted as being important for the apparently unbalanced inflammatory activity. Acne is not an infectious disease, but three major organisms were isolated from the surface of the skin and the pilosebaceous duct of patients with acne including Propionibacterium acne, Staphylococcus epidermidis and Malassezia furfur. Platelet rich plasma is a good choice for the treatment of acne and atrophic scars reminiscent of the course of the disease. In addition, for being autologous, it reduces the possibility of side effects, such as skin dryness and rejection. It was demonstrated that PRP accelerates the healing process, regulates inflammation and promotes healing by inhibiting the P. acnes bacteria, additionally restoring collagen). The PRP's mechanism of action also involves the release of powerful antimicrobial peptides from the platelets' alpha granules. Although there are few studies on the PRP's effectiveness in acne, it emerges as a potential therapeutic option in Dermatology and Aesthetic Medicine. Due to development of resistance in microorganisms causing acne to common antibiotics and differences in species and strains of the microorganisms in different regions, this study will be undertaken to determine bacteria involve in acne vulgaris and the effect of PRP on it.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Platelet-Rich Plasma, Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRP
    Arm Type
    Active Comparator
    Arm Title
    Chemical peeling (Salycilic acid)
    Arm Type
    Active Comparator
    Arm Title
    Chemical peeling (Jessenr's solution)
    Arm Type
    Active Comparator
    Intervention Type
    Combination Product
    Intervention Name(s)
    PRP
    Intervention Description
    Ten mL of venous blood will be drawn in a syringe fill with 1.5 mL of anticoagulant solution (anticoagulant citrate dextrose solution formula A, Baxter, Deerfield, IL). The blood will be centrifuged at 160 g for 10 minutes. After the first spin, the lower red blood cell portion will be discarded, and the supernatant will be centrifuged at 400 g for 10 minutes. The resulting pellet of platelets will be mixed with 1.5 mL of supernatant, which make 1.5 mL of PRP. One mL of 3% calcium chloride will be added to the PRP to induce platelet activation.
    Intervention Type
    Other
    Intervention Name(s)
    Chemical peeling (Salycilic acid)
    Intervention Description
    SA is a 2-hydroxybenzoic acid (from willow tree) used for superficial peeling due to its strong keratolytic and comedo- lytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum.19 These chemical properties explain its popularity and success in acne patients.It also has well- documented anti-inflammatory properties.
    Intervention Type
    Other
    Intervention Name(s)
    Chemical peeling (Jessener's solution)
    Intervention Description
    is a superficial peeling agent used as adjuvant therapy for acne. it is generally proposed to break of the hydrogen bonds of keratin (keratolysis), disruption of cell membranes (cell death) and is bactericidal.
    Primary Outcome Measure Information:
    Title
    Cure rate
    Description
    Assess cure rate of PRP and Chemical peeling agents in treatment of Aactive Acne Vulgaris in 3 months duration and compare efficacy of all measures
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with active acne vulgaris lesions (inflammatory and non-inflammatory). Age range from 14 to 40 years. Patients with any topical and systemic treatments will undergo wash out period of one month. Exclusion Criteria: Patients with herpes labials, or bacterial infection; warts on the face, actinic keratosis, or skin cancer or allergy to medications. Systemic retinoids intake in the previous 6 months History of keloidal scarring. Patients on anticoagulant therapy or aspirin or have a coagulation issue, Patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l Pregnant women Immunocompromised patients Patients with medical diseases like diabetes mellitus, epilepsy or malignancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Awad, PhD
    Phone
    ‭+20 102 3102094‬
    Email
    saramawad@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yassmin Mustfa Tuwfik, Lecturer
    Phone
    ‭00 20 100 6033331‬
    Email
    dr.yasminmostuwfik@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris

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