Platelet Rich PlasmaPhase 3NCT05128916
Efficacy of Intralesional PRP in Treatment of Onychomycosis
A Phase 3 study testing intralesional platelet rich plasma and Oral terbinafine in people with Platelet Rich Plasma, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Rich Plasma
- What is being tested?
- intralesional platelet rich plasma and Oral terbinafine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be adult patients (> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag University Hospital
Sohag, 82524
Reem Ali, MSc., 1096504511 ext. +20, r.e1991@yahoo.com
About this study
Official title: Efficacy of Intralesional Platelet-rich Plasma in Treatment of Onychomycosis: a Randomized Controlled Trial
This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.
Read the 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.
- Conditions
- Platelet Rich Plasma
- Being tested
- intralesional platelet rich plasma, Oral terbinafine
- Keywords
- PRP, platelet rich plasma, terbinafine, onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intralesional platelet rich plasmaBiological
Also called PRP
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 terbinafineDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Intralesional PRP | Active comparator | Patients with onychomycosis will receive intralesional injections of PRP. Receives: Biological: intralesional platelet rich plasma |
| Oral terbinafine | Active comparator | Patients with onychomycosis will receive oral terbinafine 250 mg daily Receives: Drug: Oral terbinafine |
| Intralesional PRP + Oral terbinafine | Active comparator | Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily. Receives: Biological: intralesional platelet rich plasma; Drug: Oral terbinafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Rich PlasmaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Elhaddad Ali, Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128916
- Sponsor's protocol ID
- OnychoPRP
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Platelet-rich Plasma in Treatment of Onychomycosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05128916
- Acronym / sponsor ID
- OnychoPRP
- Conditions
- Platelet Rich Plasma
- Keywords
- PRP, platelet rich plasma, terbinafine, onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intralesional PRP | Active comparator | Biological: intralesional platelet rich plasmaPatients with onychomycosis will receive intralesional injections of PRP. |
| Oral terbinafine | Active comparator | Drug: Oral terbinafinePatients with onychomycosis will receive oral terbinafine 250 mg daily |
| Intralesional PRP + Oral terbinafine | Active comparator | Biological: intralesional platelet rich plasma, Drug: Oral terbinafinePatients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be adult patients (> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..
Key exclusion criteria (5 listed)
- Patients with one or more with the following criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intralesional platelet rich plasmaAlso: PRPThree 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. | Biological | Intralesional PRP, Intralesional PRP + Oral terbinafine |
| Oral terbinafineAlso: TerbinafinePatients 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 | Drug | Intralesional PRP + Oral terbinafine, Oral terbinafine |
Primary outcome
Onychomycosis severity index
Time frame: 3 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan Saleh, MD study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intralesional platelet rich plasma and Oral terbinafine in people with Platelet Rich Plasma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Ali, MSc (1096504511 ext. +20, r.e1991@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onychomycosis severity index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.