Nail Diseases
Conditions
Keywords
Nails, brittle nail syndrome, platelet-rich plasma
Brief summary
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome
Interventions
DEVICEPlatelet-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.
DEVICEPlatelet-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.
Sponsors
Eclipse Aesthetics, LLC
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Improvement Assessment (PGIA) | At 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16 | Subjective assessments of quality of life impact due to nail health will be collected at 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one location in the United States
Pre-assignment details
A total of 11 participants passed screening and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 80 |
| 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 | 11 |
| 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 | 22 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Platelet-rich Plasma | Platelet-poor Plasma |
|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 6 | 67.8 years STANDARD_DEVIATION 6 | 67.8 years STANDARD_DEVIATION 6 |
| Modified Nail Psoriasis Quality of Life Scale (NPQ10) | 16.5 Percentage | 16.5 Percentage | 16.5 Percentage |
| Nail Superficial Abnormality Index (NSAI) | 3.5 score on a scale | 3.5 score on a scale | 3.4 score on a scale |
| Physician Global Assessment (PGA) | 3.06 score on a scale | 3.16 score on a scale | 2.7 score on a scale |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized More than one race | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 participants | 9 participants | 9 participants |
| Race/Ethnicity, Customized Unknown Ethnicity or Not Reported | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Unknown Race or Not Reported | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 10 participants | 10 participants | 10 participants |
| Region of Enrollment United States | 11 participants | 11 participants | 11 participants |
| Sex/Gender, Customized Female | 10 participants | 10 participants | 10 participants |
| Sex/Gender, Customized Male | 1 participants | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: At 16 weeks
Population: Per protocol population, defined as participants completing 16-week follow-up visit
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Platelet-rich Plasma | Physician Global Improvement Assessment (PGIA) | Good improvement | 7 Fingernails |
| Platelet-rich Plasma | Physician Global Improvement Assessment (PGIA) | No improvement | 42 Fingernails |
| Platelet-rich Plasma | Physician Global Improvement Assessment (PGIA) | Fair improvement | 9 Fingernails |
| Platelet-rich Plasma | Physician Global Improvement Assessment (PGIA) | Worse | 10 Fingernails |
| Platelet-rich Plasma | Physician Global Improvement Assessment (PGIA) | Excellent improvement | 5 Fingernails |
| Platelet-poor Plasma | Physician Global Improvement Assessment (PGIA) | Worse | 2 Fingernails |
| Platelet-poor Plasma | Physician Global Improvement Assessment (PGIA) | Excellent improvement | 2 Fingernails |
| Platelet-poor Plasma | Physician Global Improvement Assessment (PGIA) | Good improvement | 1 Fingernails |
| Platelet-poor Plasma | Physician Global Improvement Assessment (PGIA) | Fair improvement | 2 Fingernails |
| Platelet-poor Plasma | Physician Global Improvement Assessment (PGIA) | No improvement | 13 Fingernails |
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.
Time frame: Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16
Population: Per protocol population, defined as participants completing the 16-week follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Platelet-rich Plasma | 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 |