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
About this trial
This is an interventional treatment trial for Platelet-Rich Plasma
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
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
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
Learn more about this trial
Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris
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