Efficacy of Intralesional PRP in Treatment of Onychomycosis

Study Overview
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Brief Summary
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This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.

Detailed Description
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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.

Official Title
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Efficacy of Intralesional Platelet-rich Plasma in Treatment of Onychomycosis: a Randomized Controlled Trial

Conditions
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Platelet Rich Plasma

Intervention / Treatment
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* Biological: intralesional platelet rich plasma
* Drug: Oral terbinafine


Participation Criteria
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Eligibility Criteria
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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. Pregnant and lactating women. Patients received topical and/or systemic antifungal therapy during the previous 3 months. Patients with impaired liver or renal functions. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralesional PRP<br>Patients with onychomycosis will receive intralesional injections of PRP. | Biological: intralesional platelet rich plasma<br>* 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.<br>* Other names: PRP;|
| Active Comparator: Oral terbinafine<br>Patients with onychomycosis will receive oral terbinafine 250 mg daily | Drug: Oral terbinafine<br>* 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<br>* Other names: Terbinafine;|
| Active Comparator: Intralesional PRP + Oral terbinafine<br>Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily. | Biological: intralesional platelet rich plasma<br>* 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.<br>* Other names: PRP;Drug: Oral terbinafine<br>* 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<br>* Other names: Terbinafine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onychomycosis severity index | 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). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, platelet rich plasma, terbinafine, onychomycosis