Nail DiseasesPhase 4NCT04941807
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
A Phase 4 study testing Platelet-rich plasma and Platelet-poor plasma in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Diseases
- What is being tested?
- Platelet-rich plasma and Platelet-poor plasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 12 Apr 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome
- Conditions
- Nail Diseases
- Being tested
- Platelet-rich plasma, Platelet-poor plasma
- Keywords
- Nails, brittle nail syndrome, platelet-rich plasma
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaDevice
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 plasmaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Platelet-rich plasma |
| 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. Receives: Device: Platelet-poor plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 16 weeks
Secondary outcomes (1)
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.
Measured: Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start4 Mar 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nail DiseasesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Eclipse Aesthetics, LLC
- Responsible party
- Sponsor
- Investigators
- Shari R Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941807
- Sponsor's protocol ID
- 20-07022437
- Status last verified
- Mar 2024
- First submitted
- 21 Jun 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
- ClinicalTrials.gov ID
- NCT04941807
- Acronym / sponsor ID
- 20-07022437
- Conditions
- Nail Diseases
- Keywords
- Nails, brittle nail syndrome, platelet-rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Eclipse Aesthetics, LLC
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma | Experimental | Device: Platelet-rich plasmaThe 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 | Device: Platelet-poor plasmaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Inability of the patient to provide written informed consent for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasmaBlood 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. | Device | Platelet-rich plasma |
| Platelet-poor plasmaBlood 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. | Device | Platelet-poor plasma |
Primary outcome
Physician Global Improvement Assessment (PGIA)
Time frame: 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.
1 secondary outcome
Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16
Time frame: Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari R Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-rich plasma and Platelet-poor plasma in people with Nail Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Improvement Assessment (PGIA) (time frame: At 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.