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

Weill Medical College of Cornell University1 site in 1 country11 target enrollmentMarch 4, 2021

ConditionsNail Diseases

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Nail Diseases
Sponsor: Weill Medical College of Cornell University
Enrollment: 11
Locations: 1
Primary Endpoint: Physician Global Improvement Assessment (PGIA)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 4, 2021

End Date

April 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who have been diagnosed with brittle nails
•Must understand and voluntarily sign an informed consent form
•Must be male or female and aged 18-95 years at time of consent
•Must be able to adhere to the study visit schedule and other protocol requirements
•A nail clipping with histopathology that is negative for the presence of dermatophyte infection
•Patient must present with at least a score of 2 on the PGA scale.

Exclusion Criteria

•Inability of the patient to provide written informed consent for any reason.
•Subject has psoriasis, lichen planus, dermatophyte infection or other confounding abnormalities that are severe enough to result in a clinically abnormal fingernail
•Use of any medication within 90 days prior to start of study
•Inability to abstain for nail polishes, nail gels during the study period
•Subject is pregnant or planning pregnancy.

Outcomes

Primary Outcomes

Physician Global Improvement Assessment (PGIA)

Time Frame: 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.

Secondary Outcomes

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