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

Primary Purpose

Nail Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich plasma
Platelet-poor plasma
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Diseases focused on measuring Nails, brittle nail syndrome, platelet-rich plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Platelet-rich plasma

Platelet-poor plasma

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change from baseline until week 16 of follow up using the Physician Global Improvement Assessment of the 8 target nails
The PGIA will be based on a comparison of photographs taken at baseline to the nails at 4 weeks, 8 weeks, 12 weeks and week 16 of treatment and follow-up. The PGIA has five components: lamellar splitting, transverse splitting, ridging and longitudinal groove, longitudinal splitting, and nail thickness. The presence of each of these components will represent 1 point on a scale. This allows a minimum and maximum score of 0 to 5 per fingernail, respectively. A score of 0 represents no signs of brittle nail syndrome, while a score of 5 represents severe brittle nail syndrome. The mean change from baseline will be calculated at week 16.

Secondary Outcome Measures

Subject-reported assessment of nail health with a patient satisfaction survey administered at baseline and week 16.
A patient satisfaction survey assessing nail health and satisfaction with the treatment composed of 7 questions will be used. Subjects-reported assessments of nail health will be analyzed using descriptive statistics.

Full Information

First Posted
June 21, 2021
Last Updated
May 30, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Eclipse Aesthetics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04941807
Brief Title
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Official Title
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
April 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Eclipse Aesthetics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Diseases
Keywords
Nails, brittle nail syndrome, platelet-rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
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.
Arm Title
Platelet-poor plasma
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Platelet-rich plasma
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Platelet-poor plasma
Intervention Description
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 Outcome Measure Information:
Title
Mean change from baseline until week 16 of follow up using the Physician Global Improvement Assessment of the 8 target nails
Description
The PGIA will be based on a comparison of photographs taken at baseline to the nails at 4 weeks, 8 weeks, 12 weeks and week 16 of treatment and follow-up. The PGIA has five components: lamellar splitting, transverse splitting, ridging and longitudinal groove, longitudinal splitting, and nail thickness. The presence of each of these components will represent 1 point on a scale. This allows a minimum and maximum score of 0 to 5 per fingernail, respectively. A score of 0 represents no signs of brittle nail syndrome, while a score of 5 represents severe brittle nail syndrome. The mean change from baseline will be calculated at week 16.
Time Frame
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
Subject-reported assessment of nail health with a patient satisfaction survey administered at baseline and week 16.
Description
A patient satisfaction survey assessing nail health and satisfaction with the treatment composed of 7 questions will be used. Subjects-reported assessments of nail health will be analyzed using descriptive statistics.
Time Frame
Subjective assessments of nail health will be collected at baseline and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari R Lipner, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification.
IPD Sharing Time Frame
Immediately following publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data.

Learn more about this trial

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

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