Platelet Rich Plasma
Conditions
Keywords
PRP, platelet rich plasma, terbinafine, onychomycosis
Brief summary
This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.
Detailed description
Onychomycosis is a challenging medical condition with limited response to oral antifungal drugs. Recent study demonstrated that platelet rich plasma (PRP) have immuno-enhancing and antimicrobial properties. It had been shown that platelet microbicidal proteins released after platelet activation demonstrate potent activities against many gram-negative, gram-positive, and fungal pathogens in vitro and in vivo studies. In addition, white blood cell concentration in PRP was reported to be two to fourfold their normal level in whole blood. Neutrophils release myeloperoxidase which has a defensive action against fungi and bacteria, while lymphocytes and monocytes both are immunogenic cells (Badade et al., 2016). Recently, PRP was successfully used in the treatment of multiple recalcitrant plane warts (Abu El-Hamd et al., 2021), Also, PRP proved its efficacy in inhibiting periodontal pathogens such as P. gingivalis and A. actinomycetemcomitans (Badade et al., 2016). In addition, relevance of platelets for antifungal defenses might be suggested by the fact that thrombocytopenia represents a highly significant risk factor for fungal infections in post-transplant liver patients (Chang et al., 2000). This study compares between intralesional RPR versus oral antifungal versus intralesional PRP + oral antifungal in the treatment of finger nail onychmycosis.
Interventions
BIOLOGICALintralesional platelet rich plasma
Three to fifteen milliliters of blood will be drawn from each patient then evacuated after detachment of syringe needle into 15 ml conical tube containing 3.8% sodium citrate solution. Blood will be centrifuged at 300 G-force (\ 1500 RPM) for 10 minutes. This will allow the blood to separate into 3 layers: Upper platelet-poor plasma, middle platelet-rich plasma, and lower RBCs layers. The supernatant (upper third) will be removed and the middle third (PRP) will be aspirated and used for intralesional injection of affected nails.
DRUGOral terbinafine
Patients in (PRP + terbinafine) and (terbinafine) groups will receive oral 250 mg terbinafine tablets taken immediately after a fatty meal, daily for a total of 3 months
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of interventions (oral versus intralesional), both patient and treating investigator will not be blinded, but the assessment of outcome will be carried out by two dermatologists who will be blinded to the treatment type.
Intervention model description
Patients will be randomly assigned to 3 groups. In PRP group, patients with onychomycosis will receive intralesional injections of PRP (study group 1). In PRP + terbinafine group, patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily (study group 2). In terbinafine group, patients with onychomycosis will receive oral terbinafine 250 mg daily (study group 3) (control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants will be adult patients (\> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..
Exclusion criteria
* Patients with one or more with the following criteria will be excluded. 1. Pregnant and lactating women. 2. Patients received topical and/or systemic antifungal therapy during the previous 3 months. 3. Patients with impaired liver or renal functions. 4. Patients with anemia (hemoglobin level \<10mg/dl), thrombocytopenia (platelet count \< 100,000 /µL), coagulopathies or patients on anticoagulant therapy as aspirin and patients with iron deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onychomycosis severity index | 3 months | It is a quantitative score used to define the severity of onychomycosis. Briefly, OSI score is obtained by multiplying a score for the area of involvement (range, 0-5) by a score for the disease proximity to the matrix (range, 1-5). Ten points are added for the presence of a longitudinal streak or a patch (dermatophytoma) or greater than 2 mm of subungual hyperkeratosis. Mild onychomycosis corresponds to a score of 1- 5; moderate onychomycosis corresponds to a score of 6- 15, and severe onychomycosis corresponds to a score of 16- 35(Carney et al., 2011). |
Countries
Egypt
Contacts
Primary ContactReem Ali, MSc
Outcome results
None listed