Efficacy of Intralesional PRP in Treatment of Onychomycosis

Phase 3

• Conditions: Platelet Rich Plasma
• Interventions: Biological: intralesional platelet rich plasma; Drug: Oral terbinafine

• Registration Number: NCT05128916
• Lead Sponsor: Sohag University

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Last Update Submitted: 2021-11-11
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Study Start: 2021-12-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralesional PRP + Oral terbinafine	Oral terbinafine	Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.
Oral terbinafine	Oral terbinafine	Patients with onychomycosis will receive oral terbinafine 250 mg daily
Intralesional PRP	intralesional platelet rich plasma	Patients with onychomycosis will receive intralesional injections of PRP.
Intralesional PRP + Oral terbinafine	intralesional platelet rich plasma	Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt