Trial Outcomes & Findings for Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome (NCT NCT04941807)
NCT ID: NCT04941807
Last Updated: 2024-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
At 16 weeks
Results posted on
2024-04-23
Participant Flow
Participants were recruited from one location in the United States
A total of 11 participants passed screening and were randomized.
Unit of analysis: Fingernails
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11 80
|
11 22
|
|
Overall Study
COMPLETED
|
10 73
|
10 20
|
|
Overall Study
NOT COMPLETED
|
1 7
|
1 2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Baseline characteristics by cohort
| Measure |
Platelet-rich Plasma
n=80 Fingernails
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.
|
Platelet-poor Plasma
n=22 Fingernails
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
|
Total
n=102 Fingernails
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 6 • n=99 Participants
|
67.8 years
STANDARD_DEVIATION 6 • n=107 Participants
|
67.8 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown Race or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown Ethnicity or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Physician Global Assessment (PGA)
|
3.16 score on a scale
n=80 Fingernails
|
2.7 score on a scale
n=22 Fingernails
|
3.06 score on a scale
n=102 Fingernails
|
|
Nail Superficial Abnormality Index (NSAI)
|
3.5 score on a scale
n=80 Fingernails
|
3.4 score on a scale
n=22 Fingernails
|
3.5 score on a scale
n=102 Fingernails
|
|
Modified Nail Psoriasis Quality of Life Scale (NPQ10)
|
16.5 Percentage
n=99 Participants
|
16.5 Percentage
n=107 Participants
|
16.5 Percentage
n=206 Participants
|
PRIMARY outcome
Timeframe: At 16 weeksPopulation: Per protocol population, defined as participants completing 16-week follow-up visit
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.
Outcome measures
| Measure |
Platelet-rich Plasma
n=73 Fingernails
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.
|
Platelet-poor Plasma
n=20 Fingernails
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.
|
|---|---|---|
|
Physician Global Improvement Assessment (PGIA)
Excellent improvement
|
5 Fingernails
|
2 Fingernails
|
|
Physician Global Improvement Assessment (PGIA)
Good improvement
|
7 Fingernails
|
1 Fingernails
|
|
Physician Global Improvement Assessment (PGIA)
Fair improvement
|
9 Fingernails
|
2 Fingernails
|
|
Physician Global Improvement Assessment (PGIA)
No improvement
|
42 Fingernails
|
13 Fingernails
|
|
Physician Global Improvement Assessment (PGIA)
Worse
|
10 Fingernails
|
2 Fingernails
|
SECONDARY outcome
Timeframe: Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16Population: Per protocol population, defined as participants completing the 16-week follow-up visit.
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.
Outcome measures
| Measure |
Platelet-rich Plasma
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16
|
10 percentage
Interval 0.0 to 60.0
|
—
|
Adverse Events
Platelet-rich Plasma
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Platelet-poor Plasma
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Platelet-rich Plasma
n=10 participants at risk
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.
|
Platelet-poor Plasma
n=10 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Subungual hematoma
|
30.0%
3/10 • 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.
|
20.0%
2/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
20.0%
2/10 • 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.
|
20.0%
2/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Leukonychia
|
10.0%
1/10 • 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.
|
0.00%
0/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Beau's line(s)
|
10.0%
1/10 • 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.
|
0.00%
0/10 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place