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

Study Overview
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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

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

Conditions
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Nail Diseases

Intervention / Treatment
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* Device: Platelet-rich plasma
* Device: Platelet-poor plasma


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-rich plasma<br>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<br>* 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.<br>|
| Placebo Comparator: Platelet-poor plasma<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Subjective assessments of nail health will be collected at baseline and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nails, brittle nail syndrome, platelet-rich plasma