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Completed

NCT Number: NCT04941807

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

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

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Key information

Conditions

Nail Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. 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

  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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Eclipse Aesthetics, LLC

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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