Efficacy of Intralesional PRP in Treatment of Onychomycosis

Platelet Rich Plasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05128916
• Other study ID #: OnychoPRP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: Reem Ali, MSc
• Phone: 1096504511
• Email: r.e1991[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis
• Platelet Rich Plasma

Intervention

Biological:
• intralesional 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.

Drug:
• Oral 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

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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