Clinical trial NCT05128916: Efficacy of Intralesional PRP in Treatment of Onychomycosis
Official title: Efficacy of Intralesional Platelet-rich Plasma in Treatment of Onychomycosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Platelet Rich Plasma
Keywords: PRP, platelet rich plasma, terbinafine, onychomycosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Onychomycosis severity index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag University
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References: