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

Nail Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941807
• Other study ID #: 20-07022437
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2021
• Est. completion date: April 12, 2023

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nail Diseases

Intervention

Device:
• Platelet-rich plasma
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-poor plasma
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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Eclipse Aesthetics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between 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.	Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16