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

NCT04941807 | Completed Phase 4 Results FDA Device

• 1 other identifier: 20-07022437
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nail Diseases

Keywords

Nails; brittle nail syndrome; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Physician Global Improvement Assessment (PGIA)

  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.

  At 16 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Platelet-rich plasma

EXPERIMENTAL

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.

Device: Platelet-rich plasma

Platelet-poor plasma

PLACEBO COMPARATOR

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.

Device: Platelet-poor plasma

Interventions

Platelet-rich plasma DEVICE

Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-rich plasma is injected into 8 proximal nail folds.

Platelet-rich plasma

Platelet-poor plasma DEVICE

Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-poor plasma is injected into 2 proximal nail folds.

Platelet-poor plasma

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Eclipse Aesthetics, LLC: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Nail Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Shari Lipner
• Organization: Weill Cornell Medicine

shl9032@med.cornell.edu

6469623376

Study Officials

• Shari R Lipner, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 28, 2021
• Study Start: March 4, 2021
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)