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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04941807

Collaborator

Eclipse Aesthetics, LLC (Other)

Enrollment

Location

Arms

32.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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 :

Mar 4, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 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.

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

Mean change from baseline until week 16 of follow up using the Physician Global Improvement Assessment of the 8 target nails [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

Subject-reported assessment of nail health with a patient satisfaction survey administered at baseline and week 16. [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University
Eclipse Aesthetics, LLC

Investigators

Principal Investigator: Shari R Lipner, MD, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT04941807

Other Study ID Numbers:

20-07022437

First Posted:

Jun 28, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Weill Medical College of Cornell University

Nails

brittle nail syndrome

platelet-rich plasma

Additional relevant MeSH terms:

Nail Diseases

Study Results

No Results Posted as of Jul 20, 2022