Clinical trial NCT03859843: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Platelet-Rich Plasma
Acne Vulgaris
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cure rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
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