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| Name | Class |
|---|---|
| Eclipse Aesthetics, LLC | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma | Experimental | 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. |
|
| Platelet-poor plasma | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Improvement Assessment (PGIA) | The PGIA will be based on a comparison of photographs taken at baseline to the nails at week 16 of follow-up. The Physician Global Improvement Score (PGIA) evaluates the improvement of lamellar splitting, transverse splitting, ridges, longitudinal grooves, longitudinal splitting, and nail thickness in target fingernails. Change is classified as excellent, good, or fair, or categorized as no improvement or worsening. | At 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16 | The modified NPQ10 comprises 10 questions gauging the impact of brittle nail syndrome on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, ranging from 0% to 100%, with higher percentages indicating higher functional difficulty experienced. The absolute change in NPQ10 percentage score from baseline to week 16 is reported here. |
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Inclusion Criteria:
Exclusion Criteria:
Inability of the patient to provide written informed consent for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Shari R Lipner, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification.
Immediately following publication.
Anyone who wishes to access the data.
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A total of 11 participants passed screening and were randomized.
Participants were recruited from one location in the United States
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma | The proximal nail fold is cleansed with alcohol and 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 the proximal nail folds. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Global Improvement Assessment (PGIA) | The PGIA will be based on a comparison of photographs taken at baseline to the nails at week 16 of follow-up. The Physician Global Improvement Score (PGIA) evaluates the improvement of lamellar splitting, transverse splitting, ridges, longitudinal grooves, longitudinal splitting, and nail thickness in target fingernails. Change is classified as excellent, good, or fair, or categorized as no improvement or worsening. | Per protocol population, defined as participants completing 16-week follow-up visit | Posted | Count of Units | Fingernails | At 16 weeks | Fingernails | Fingernails |
|
16 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subungual hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 3/73 in the platelet-rich plasma group 1/20 in the platelet-poor plasma group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shari Lipner | Weill Cornell Medicine | 6469623376 | shl9032@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2023 | Feb 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
|
| Platelet-poor plasma | 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. |
|
| Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16 |
| BG001 | Platelet-poor Plasma | The proximal nail fold is cleansed with alcohol and 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 the proximal nail folds. 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 |
| BG002 | Total | Total of all reporting groups |
| Fingernails |
|
| years |
| Participants |
|
| Sex/Gender, Customized | Number | participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Physician Global Assessment (PGA) | The Physician Global Assessment evaluates the presence and severity of five features that may occur in patients with brittle nail syndrome. Each component is scored from 0 to 3, with 3 indicating the most severe features. This results in a final score per fingernail ranging from 0 to 15. The obtained score correlates proportionally with the severity level of brittle nail syndrome. | Mean | Full Range | score on a scale | Fingernails |
|
| Nail Superficial Abnormality Index (NSAI) | The Nail Surface Abnormality Index (NSAI) assesses four parameters-pitting, discoloration, longitudinal ridging, and horizontal ridging-across four quadrants of the nail plate. Each parameter is assigned a score of 1 for presence or 0 for absence. Consequently, the highest achievable score for a nail ranges from 0 to 16, indicating the most severe abnormality. | Mean | Full Range | score on a scale | Fingernails |
|
| Modified Nail Psoriasis Quality of Life Scale (NPQ10) | The modified NPQ10 comprises 10 questions gauging the impact of brittle nail syndrome on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, ranging from 0% to 100%, with higher percentages indicating higher functional difficulty experienced. The value reported is the average score for all study participants. | Mean | Full Range | Percentage | Participants |
|
| OG001 | 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. 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. |
|
|
| Secondary | Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16 | The modified NPQ10 comprises 10 questions gauging the impact of brittle nail syndrome on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, ranging from 0% to 100%, with higher percentages indicating higher functional difficulty experienced. The absolute change in NPQ10 percentage score from baseline to week 16 is reported here. | Per protocol population, defined as participants completing the 16-week follow-up visit. | Posted | Mean | Full Range | percentage | Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 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. 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. | 0 | 10 | 0 | 10 | 4 | 10 |
|
| Onychomadesis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 4/73 in the platelet-rich plasma group 2/20 in the platelet-poor plasma group |
|
| Leukonychia | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 1/73 in the platelet-rich plasma group 0/20 in the platelet-poor plasma group |
|
| Beau's line(s) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 1/73 in the platelet-rich plasma group 0/20 in the platelet-poor plasma group |
|
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