Efficacy of Intralesional PRP in Treatment of Onychomycosis

NCT05128916 | Unknown Phase 3

• 1 other identifier: OnychoPRP
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Platelet Rich Plasma

Keywords

PRP, platelet rich plasma, terbinafine, onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Study Arms (3)

Intralesional PRP

ACTIVE COMPARATOR

Patients with onychomycosis will receive intralesional injections of PRP.

Biological: intralesional platelet rich plasma

Oral terbinafine

ACTIVE COMPARATOR

Patients with onychomycosis will receive oral terbinafine 250 mg daily

Drug: Oral terbinafine

Intralesional PRP + Oral terbinafine

ACTIVE COMPARATOR

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

Biological: intralesional platelet rich plasma; Drug: Oral terbinafine

Interventions

intralesional platelet rich plasma 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.

Also known as: PRP

Intralesional PRP; Intralesional PRP + Oral terbinafine

Oral terbinafine 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

Also known as: Terbinafine

Intralesional PRP + Oral terbinafine; Oral terbinafine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be adult patients (\> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ramadan Saleh, MD

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Reem Ali, MSc

CONTACT

1096504511; r.e1991@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Dermatology, Venereology and Andrology

Model Details: 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)

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 22, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)