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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2023-04-12

Brief Summary

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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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Detailed Description

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Conditions

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Nail Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.

Study Groups

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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.

Group Type EXPERIMENTAL

Platelet-rich plasma

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Platelet-poor plasma

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No