NCT04941807

Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome

Completed Phase 4 Results posted Last updated 23 April 2024

What this trial tests

Phase 4 trial testing Platelet-rich plasma in Nail Diseases in 11 participants. Completed in 12 April 2023.

Timeline

4 March 2021

Primary endpoint
12 April 2023

12 April 2023

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	11
Start date	4 March 2021
Primary completion	12 April 2023
Estimated completion	12 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Platelet-rich plasma
• Platelet-poor plasma

Conditions studied

• Nail Diseases — all drugs for Nail Diseases →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Nail Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Physician Global Improvement Assessment (PGIA) Primary · At 16 weeks

The PGIA will be based on a comparison of photographs taken at baseline to the nails at week 16 of follow-up. The Physician Global Improvement Score (PGIA) evaluates the improvement of lamellar splitting, transverse splitting, ridges, longitudinal grooves, longitudinal splitting, and nail thickness in target fingernails. Change is classified as excellent, good, or fair, or categorized as no improvement or worsening.

Excellent improvement

Group	Value	95% CI
Platelet-rich Plasma	5
Platelet-poor Plasma	2

Good improvement

Group	Value	95% CI
Platelet-rich Plasma	7
Platelet-poor Plasma	1

Fair improvement

Group	Value	95% CI
Platelet-rich Plasma	9
Platelet-poor Plasma	2

No improvement

Group	Value	95% CI
Platelet-rich Plasma	42
Platelet-poor Plasma	13

Worse

Group	Value	95% CI
Platelet-rich Plasma	10
Platelet-poor Plasma	2

Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16 Secondary · Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16

The modified NPQ10 comprises 10 questions gauging the impact of brittle nail syndrome on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, ranging from 0% to 100%, with higher percentages indicating higher functional difficulty experienced. The absolute change in NPQ10 percentage score from baseline to week 16 is reported here.

Group	Value	95% CI
All Groups	10	0 – 60

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Platelet-rich Plasma

Serious: 0/10 (0%)

Deaths: 0/10

Platelet-poor Plasma

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (4 terms — click to expand)

Reaction	System	Platelet-rich Plasma	Platelet-poor Plasma
Subungual hematoma	Skin and subcutaneous tissue disorders	—	—
Onychomadesis	Skin and subcutaneous tissue disorders	—	—
Leukonychia	Skin and subcutaneous tissue disorders	—	—
Beau's line(s)	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04941807 adverse events section.

Sponsor's own description

The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.