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Efficacy of Intralesional PRP in Treatment of Onychomycosis

Primary Purpose

Platelet Rich Plasma

Status
Not yet recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
intralesional platelet rich plasma
Oral terbinafine
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet Rich Plasma focused on measuring PRP, platelet rich plasma, terbinafine, onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intralesional PRP

Oral terbinafine

Intralesional PRP + Oral terbinafine

Arm Description

Patients with onychomycosis will receive intralesional injections of PRP.

Patients with onychomycosis will receive oral terbinafine 250 mg daily

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 11, 2021
Last Updated
November 11, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05128916
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Rich Plasma
Keywords
PRP, platelet rich plasma, terbinafine, onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intralesional PRP
Arm Type
Active Comparator
Arm Description
Patients with onychomycosis will receive intralesional injections of PRP.
Arm Title
Oral terbinafine
Arm Type
Active Comparator
Arm Description
Patients with onychomycosis will receive oral terbinafine 250 mg daily
Arm Title
Intralesional PRP + Oral terbinafine
Arm Type
Active Comparator
Arm Description
Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.
Intervention Type
Biological
Intervention Name(s)
intralesional platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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
Drug
Intervention Name(s)
Oral terbinafine
Other Intervention Name(s)
Terbinafine
Intervention Description
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
Primary Outcome Measure Information:
Title
Onychomycosis severity index
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Pregnant and lactating women. Patients received topical and/or systemic antifungal therapy during the previous 3 months. Patients with impaired liver or renal functions. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Ali, MSc
Phone
1096504511
Ext
+20
Email
r.e1991@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramadan Saleh, MD
Organizational Affiliation
Sohag University
Official's Role
Study Director
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Ali, MSc.
Phone
1096504511
Ext
+20
Email
r.e1991@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Intralesional PRP in Treatment of Onychomycosis

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