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出境医 / 临床实验 / Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome

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

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

Condition or disease Intervention/treatment Phase
Nail Diseases Device: Platelet-rich plasma Device: Platelet-poor plasma Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
Primary Purpose: Treatment
Official Title: Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 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.
Placebo Comparator: 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.
 Device: 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.
Outcome Measures
Primary Outcome Measures :
  1. Mean change from baseline until week 16 of follow up using the Physician Global Improvement Assessment of the 8 target nails [ Time Frame: At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
    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 :
  1. Subject-reported assessment of nail health with a patient satisfaction survey administered at baseline and week 16. [ Time Frame: Subjective assessments of nail health will be collected 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Jose W Ricardo, MD 9172937853 jw.ricardo175@gmail.com

Locations
Layout table for location information
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Shari R Lipner, MD, PhD    646-962-3376    shl9032@med.cornell.edu   
Principal Investigator: Shari R Lipner, MD, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Eclipse Aesthetics, LLC
Investigators
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Principal Investigator: Shari R Lipner, MD, PhD Weill Medical College of Cornell University
Tracking Information
First Submitted Date  ICMJE June 21, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE March 4, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2021) 		Mean change from baseline until week 16 of follow up using the Physician Global Improvement Assessment of the 8 target nails [ Time Frame: At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2021) 		Subject-reported assessment of nail health with a patient satisfaction survey administered at baseline and week 16. [ Time Frame: Subjective assessments of nail health will be collected 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Official Title  ICMJE Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
Primary Purpose: Treatment
Condition  ICMJE Nail Diseases
Intervention  ICMJE
  • 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.
  • Device: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: Platelet-rich plasma
  • Placebo Comparator: 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.
    Intervention: Device: Platelet-poor plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2021) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose W Ricardo, MD 9172937853 jw.ricardo175@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941807
Other Study ID Numbers  ICMJE 20-07022437
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification.
Supporting Materials: Study Protocol
Time Frame: Immediately following publication.
Access Criteria: Anyone who wishes to access the data.
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Eclipse Aesthetics, LLC
Investigators  ICMJE
Principal Investigator: Shari R Lipner, MD, PhD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP