Platelet-Rich Plasma for Central Centrifugal Alopecia

Overseen By Chidimma Okwara, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Must be taking: Topical steroids

Must not be taking: Anti-inflammatories, Immunosuppressives, Antiplatelets, Minoxidil

Disqualifiers: Pregnancy, Severe CCCA, Thrombocytopenia, others

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

Compensation: Varies

Number of Visits: 7

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if platelet-rich plasma (PRP) injections can treat central centrifugal cicatricial alopecia (CCCA), a type of scarring hair loss primarily affecting women of African descent. PRP, derived from the participant's own blood, may reduce inflammation and promote hair regrowth. Participants will receive either PRP or a placebo (inactive treatment) alongside standard care. Women of African descent diagnosed with mild to moderate CCCA, particularly those experiencing symptoms like itching or burning on the scalp, are well-suited for the study. The goal is to find better ways to manage and treat CCCA, which currently lacks standard treatment guidelines. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you should not have taken anti-inflammatory or immunosuppressive drugs, topical minoxidil, metformin, retinoic acid, or antiplatelet medications for at least 4 weeks before starting the study.

What is the safety track record for Platelet-Rich Plasma (PRP) Injections?

Previous studies have shown that platelet-rich plasma (PRP) injections are safe for treating other types of hair loss, such as androgenetic alopecia. These studies highlight PRP's ability to reduce inflammation, which can help with scalp issues. Reports indicate that patients generally tolerate PRP well, with only minor side effects like temporary pain or swelling at the injection site.

For cicatricial alopecia, including conditions like central centrifugal cicatricial alopecia (CCCA), early reports also suggest PRP is safe. Although more research is needed to confirm its effectiveness specifically for CCCA, existing safety data from other conditions is promising. Participants in these studies have not reported serious side effects. This background provides reassurance about the safety of PRP for those considering joining a clinical trial for CCCA treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Platelet-Rich Plasma (PRP) injections for central centrifugal alopecia because PRP uses the body's own platelets to potentially stimulate hair growth. Unlike standard treatments such as topical corticosteroids or minoxidil, PRP is derived from a patient's blood, which might enhance its effectiveness and reduce the risk of side effects. This method targets the scalp directly with growth factors that could promote hair regeneration in a way that current treatments do not. By harnessing the body's natural healing processes, PRP may provide a more holistic and personalized approach to managing hair loss.

What evidence suggests that platelet-rich plasma might be an effective treatment for central centrifugal alopecia?

Studies have shown that platelet-rich plasma (PRP) injections can improve hair conditions, including central centrifugal cicatricial alopecia (CCCA). Research indicates that after about four PRP sessions, 73% of patients show improvement, with 75% of those with CCCA noticing benefits. In this trial, participants in different treatment arms will receive varying numbers of PRP injections to evaluate its effectiveness. PRP uses components of the patient's own blood to reduce inflammation and promote healing, potentially leading to thicker and denser hair. Additionally, PRP has been noted to reduce symptoms like scalp itching and redness. While PRP is already used for other hair loss conditions, these findings suggest it could be promising for CCCA as well. ^{1 4 6 7 8}

Who Is on the Research Team?

Oyetewa Asempa, MD

Principal Investigator

Baylor College of Medicine

Assistant Professor of Dermatology

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for women of African descent with mild to moderate CCCA, a scarring hair loss condition. Participants must be diagnosed with CCCA and will continue using topical steroids. The study excludes those who don't meet the specific demographic or disease severity criteria.

Inclusion Criteria

Self-identification as person of African descent, including African, Afro-Caribbean, Afro-Latino, and/or African American

I am female.

I am at least 18 years old.

Exclusion Criteria

Pregnant women

Thrombocytopenia (as defined by baseline platelet count < 150,000 platelets per microliter of blood)

My central hair loss is severe, beyond stage 3B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PRP or placebo injections. Treatment arm 1 receives three injections at weeks 0, 4, and 8. Treatment arm 2 receives four injections at weeks 0, 4, 8, and 20.

20 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hair regrowth and adverse events.

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma (PRP) Injections

Trial Overview The study tests if PRP injections can treat CCCA by promoting healing and stopping hair loss. Women will either receive PRP from their own blood or a saline placebo in a randomized, double-blind setup while continuing standard steroid treatment.

How Is the Trial Designed?

Group I: Treatment arm 2 Experimental Treatment 1 Intervention

In treatment arm 2, participants will receive a total of four PRP injections; the first three spaced four weeks apart (Week 0, Week 4, Week 8), and a final injection twelve weeks later (Week 20).

Group II: Treatment arm 1 Experimental Treatment 1 Intervention

In treatment arm 1, participants will receive a total of three PRP injections spaced four weeks apart (Week 0, Week 4, Week 8).

Group III: Placebo arm 1 Placebo Group 1 Intervention

In Placebo arm 1, participants will receive a total of three saline injections spaced four weeks apart (Week 0, Week 4, Week 8).

Group IV: Placebo arm 2 Placebo Group 1 Intervention

In placebo arm 2, participants will receive a total of four saline injections; the first three spaced four weeks apart (Week 0, Week 4, Week 8), and a final injection twelve weeks later (Week 20).

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9786548/

Transitory hair growth using platelet‐rich plasma therapy in ... The investigators also noted a reduction in the follicular density 6 months after treatment, supporting the need for maintenance therapy. These decrease in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06998433

Effect of Platelet-Rich Plasma Versus Placebo in the ... This study aims to investigate whether platelet-rich plasma (PRP) injections can help treat central centrifugal cicatricial alopecia (CCCA).

3. jaad.org jaad.org/article/S0190-9622(23)02044-3/fulltext

43399 Growing uses of PRP: an evaluation of hair growth ... PRP has shown to decrease perifollicular erythema, scaling, and scalp itching, and increase hair density and thickness in 15 out of 19 patients.

4. dermatologytimes.com dermatologytimes.com/view/platelet-rich-plasma-shows-promising-results-for-cicatricial-alopecia-in-soc-patients

Platelet-Rich Plasma Shows Promising Results for ... After an average of 4 platelet-rich plasma sessions at 4-to-6-week intervals, 73% (n=11) showed improvements, including 75% (n=6) with CCCA, 13% ...

5. cureus.com cureus.com/articles/394231-central-centrifugal-cicatricial-alopecia-a-survey-of-treatment-practices-among-dermatology-residents-and-attending-physicians

Central Centrifugal Cicatricial Alopecia: A Survey of ... We conducted a cross-sectional survey study of the commonly prescribed/recommended treatments for CCCA in 31 residents and attending physicians ...

6. blog.scarringalopecia.org blog.scarringalopecia.org/medical-articles/19426-2

Platelet-rich Plasma in Central Centrifugal Cicatricial ... PRP has proven to be a safe and effective therapy for nonscarring androgenetic alopecia (AGA)5,6,7. Given its anti-inflammatory properties as ...

7. jaad.org jaad.org/article/S0190-9622(24)00308-6/abstract

Treatment for central centrifugal cicatricial alopecia— ... There is no established standard of care for treating central centrifugal cicatricial alopecia (CCCA), and treatment approaches vary widely.

8. jaadinternational.org jaadinternational.org/article/S2666-3287(21)00018-3/fulltext

Undiagnosed cicatricial alopecia among new patients ... Preliminary reports of PRP therapy for the treatment of cicatricial (scarring) alopecia suggest that it is safe, but its efficacy remains ...