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

Phase 4

Completed

• Conditions: Nail Diseases
• Interventions: Device: Platelet-poor plasma; Device: Platelet-rich plasma

• Registration Number: NCT04941807
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-28
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Results First Submitted: 2024-02-15
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-23
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-poor plasma	Platelet-poor plasma	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.
Platelet-rich plasma	Platelet-rich plasma	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.

Primary Outcome Measures

Name	Time	Method
Physician Global Improvement Assessment (PGIA)	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States