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Efficacy of Intralesional PRP in Treatment of Onychomycosis

NCT ID: NCT05128916

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-01

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.

Conditions

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Platelet Rich Plasma

Keywords

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PRP, platelet rich plasma, terbinafine, onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the nature of interventions (oral versus intralesional), both patient and treating investigator will not be blinded, but the assessment of outcome will be carried out by two dermatologists who will be blinded to the treatment type.

Study Groups

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Intralesional PRP

Patients with onychomycosis will receive intralesional injections of PRP.

Group Type ACTIVE_COMPARATOR

intralesional platelet rich plasma

Intervention Type BIOLOGICAL

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.

Oral terbinafine

Patients with onychomycosis will receive oral terbinafine 250 mg daily

Group Type ACTIVE_COMPARATOR

Oral terbinafine

Intervention Type DRUG

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

Intralesional PRP + Oral terbinafine

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

Group Type ACTIVE_COMPARATOR

intralesional platelet rich plasma

Intervention Type BIOLOGICAL

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.

Oral terbinafine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

Other Intervention Names

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PRP Terbinafine

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Reem Elhaddad Ali

Assistant lecturer of Dermatology, Venereology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan Saleh, MD

Role: STUDY_DIRECTOR

Sohag University

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Reem Ali, MSc

Role: CONTACT

Phone: 1096504511

Email: [email protected]

Facility Contacts

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Reem Ali, MSc.

Role: primary

Other Identifiers

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OnychoPRP

Identifier Type: -

Identifier Source: org_study_id