Efficacy of Intralesional PRP in Treatment of Onychomycosis

Sohag University

Status and phase: Unknown; Phase 3

Conditions: Platelet Rich Plasma

Treatments: Drug: Oral terbinafine; Biological: intralesional platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05128916

OnychoPRP

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Intralesional PRP

Active Comparator group

Description:

Patients with onychomycosis will receive intralesional injections of PRP.

Treatment:

Biological: intralesional platelet rich plasma

Oral terbinafine

Active Comparator group

Description:

Patients with onychomycosis will receive oral terbinafine 250 mg daily

Treatment:

Drug: Oral terbinafine

Intralesional PRP + Oral terbinafine

Active Comparator group

Description:

Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.

Treatment:

Biological: intralesional platelet rich plasma

Drug: Oral terbinafine