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Biological
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Phase 4
Waitlist Available
Led By Shari R Lipner, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 16 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing a treatment where a patient's own blood is used to help heal and strengthen weak, breakable nails. The treatment aims to use special components in the blood to repair the nails.
Eligible Conditions
- Nail Diseases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physician Global Improvement Assessment (PGIA)
Secondary study objectives
Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16
Side effects data
From 2023 Phase 4 trial • 11 Patients • NCT0494180730%
Subungual hematoma
20%
Onychomadesis
10%
Leukonychia
10%
Beau's line(s)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Platelet-rich Plasma
Platelet-poor Plasma
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-rich plasmaExperimental Treatment1 Intervention
The proximal nail fold is cleansed with alcohol and platelet-rich plasma obtained from the patient is injected using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-rich plasma is injected into 8 proximal nail folds.
Group II: Platelet-poor plasmaPlacebo Group1 Intervention
The proximal nail fold is cleansed with alcohol and platelet-poor plasma obtained from the patient is injected using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-poor plasma is injected into 2 proximal nail folds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich plasma
2016
Completed Phase 4
~360
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,734 Total Patients Enrolled
4 Trials studying Nail Diseases
31 Patients Enrolled for Nail Diseases
Eclipse Aesthetics, LLCOTHER
2 Previous Clinical Trials
70 Total Patients Enrolled
Shari R Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
2 Trials studying Nail Diseases