Platelet-rich Plasma for Nail Diseases

Overseen By Jose W Ricardo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Any medication

Disqualifiers: Psoriasis, Lichen planus, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet-rich plasma (PRP) therapy can safely and effectively treat brittle nail syndrome. PRP involves injecting a special component of a person's own blood into the nail area to strengthen and heal the nails. Some participants will receive PRP, while others will receive a placebo (a harmless substitute) for comparison. The study seeks individuals diagnosed with brittle nails who can commit to the study schedule. It offers a chance to try a potential new treatment that could improve daily life for those with weak nails. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how PRP benefits more patients with brittle nail syndrome.

Will I have to stop taking my current medications?

Yes, you must stop taking any medications at least 90 days before the study starts.

What is the safety track record for these treatments?

Research has shown that platelet-rich plasma (PRP) injections are generally safe and usually do not cause major side effects. However, minor issues can occur, such as mild swelling, pain at the injection site, or, very rarely, infections. Clean injection methods help reduce the risk of infection. Although reports of more serious problems like blindness or allergic reactions exist, these are very rare. Overall, PRP therapy is considered safe for most people, with serious issues being quite uncommon. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike typical treatments for brittle nail syndrome, which often include topical creams or oral supplements, platelet-rich plasma (PRP) therapy offers a unique approach by using the patient's own blood components. Researchers are excited because PRP is directly injected into the nail fold, potentially promoting natural healing and regeneration from within. This method targets the underlying issue more directly than traditional treatments, which typically focus on surface-level symptoms. Plus, using one's own plasma reduces the risk of adverse reactions, making it a promising alternative for improving nail health.

What evidence suggests that platelet-rich plasma therapy might be an effective treatment for brittle nail syndrome?

Research has shown that platelet-rich plasma (PRP) therapy holds promise for treating various conditions. In this trial, participants will receive either PRP or platelet-poor plasma (PPP) as a comparator. For brittle nail syndrome, early reports indicate that nail health can improve within weeks of PRP treatment. Some patients experienced significant improvements in as little as three weeks, with no issues returning for months. PRP is a treatment derived from a person's own blood, which is then injected to aid healing and tissue growth. Studies generally report positive results, suggesting PRP is a safe and effective option. Overall, PRP offers a promising and body-friendly treatment for brittle nails. ^{6 7 8 9 10}

Who Is on the Research Team?

Shari R Lipner, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with brittle nails.

Must understand and voluntarily sign an informed consent form

Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

You have a severe skin condition, such as psoriasis or fungal infection, that affects your fingernails.

Use of any medication within 90 days prior to start of study

Inability of the patient to provide written informed consent for any reason.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of platelet-rich plasma or platelet-poor plasma into the proximal nail folds

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-poor plasma
• Platelet-rich plasma

How Is the Trial Designed?

Group I: Platelet-rich plasma Experimental Treatment 1 Intervention

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.

Group II: Platelet-poor plasma Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Eclipse Aesthetics, LLC

Collaborator

Trials

3

Recruited

80+

Published Research Related to This Trial

Avatrombopag significantly increased platelet response in patients with thrombocytopenia compared to placebo, with a notable absolute increment in platelet count of 31.13%.

While avatrombopag was effective, it was associated with a slightly higher incidence of adverse events compared to placebo, although serious adverse events and mortality rates were not significantly different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Li, C., Li, X., Huang, F., et al.[2020]

Interleukin-11 has been approved by the FDA for reducing severe thrombocytopenia in patients undergoing intensive chemotherapy, demonstrating its efficacy in this specific context.

While thrombopoietin and its analogues are potent stimulators of platelet production with few side effects, their effectiveness in preventing severe thrombocytopenia during leukemia treatment and bone marrow transplants has been disappointing, and some can induce harmful antibodies that lead to thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical biology and potential use of thrombopoietin. Basser, R.[2019]

Platelet-rich plasma (PRP) significantly enhances the proliferation of human adipose-derived stem cells (hASCs), primarily through the action of platelet-derived growth factor (PDGF)-BB.

The proliferation induced by PRP is mediated via specific signaling pathways, including ERK1/2, PI3K/Akt, and JNK, while inhibitors like imatinib and sorafenib can effectively block this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma enhances the proliferation of human adipose stem cells through multiple signaling pathways. Lai, F., Kakudo, N., Morimoto, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04941807?term=AREA%5BConditionSearch%5D(nail)&rank=5

Use of Platelet-rich Plasma (PRP) Therapy in Patients With ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8675348/

Platelet-Rich Plasma: A Comprehensive Review of Emerging ... Most studies reported favorable outcomes. PRP offers a convenient, biocompatible therapeutic option that has not only produced clinical improvement in multiple ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT04941807/Prot_SAP_000.pdf

Use of Platelet-rich plasma (PRP) therapy in patients with ... The Primary efficacy endpoint will be the change in the Physician Global Improvement. Assessment (PGIA) of the 8 target nails from baseline to weeks 12 – 14 of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dth.12831

Intramatricial platelet‐rich plasma therapy: A novel ... Case 1 showed marked improvement within 3 weeks and Case 2 showed improvement within 6 weeks. No relapses were seen at 16 and 20 weeks of follow ...

5. jcadonline.com jcadonline.com/platelet-rich-plasma-review/

Progress in the Use of Platelet-rich Plasma in Aesthetic ... PRP, used alone or in combination with other therapies, showed beneficial effects in terms of cosmetic improvements and for some skin diseases.

6. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/plateletrich-plasma-prp-treatment

Platelet-Rich Plasma (PRP) Injections A PRP injection is a low-risk procedure and does not usually cause major side effects. The procedure involves a blood draw, so you should make sure you are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424001329

Adverse events related to platelet-rich plasma therapy and ... PRP therapy may involve several AEs, including postoperative infections, blindness, inflammation, allergic reactions, and nodule development.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10725573/

A Comprehensive Review on Platelet-Rich Plasma Activation Infection risks: PRP therapy, especially when administered through injections, carries a potential risk of infection. Maintaining strict aseptic ...

9. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39058

Platelet Rich Plasma Injections for Non-Wound Injections Use this page to view details for the Local Coverage Determination for Platelet Rich Plasma Injections for Non-Wound Injections.

10. uchealth.org uchealth.org/treatments-procedures/platelet-rich-plasma-prp-therapy/

Platelet Rich Plasma PRP Therapy | Natural and Safe Infection: Although rare, there is a small risk of infection at the injection site. Strict sterile techniques during the procedure help minimize this risk. Pain ...