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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to investigate whether platelet-rich plasma (PRP) injections can help treat central centrifugal cicatricial alopecia (CCCA), a type of scarring hair loss that mostly affects women of African descent. CCCA is a condition that leads to permanent hair loss, usually starting at the top of the scalp and spreading outward. It can also cause discomfort, such as itching, burning, and pain. The goal is to see if PRP, which comes from the patient's own blood and is thought to reduce inflammation and promote healing, can stop hair loss and even encourage hair regrowth. PRP has been used to treat other types of hair loss, but it has not been widely studied for CCCA. Participants in the study will be women of African descent who have been diagnosed with mild to moderate CCCA. Some participants will receive PRP injections, while others will receive a placebo (an inactive treatment) as part of a randomized, double-blind trial. All participants will continue using a topical steroid treatment, which is the standard of care for this condition. The study will also look at growth factors in participants' blood to understand how they may affect hair loss or regrowth. The goal is to gather information that could lead to better treatments for CCCA, a condition that currently has no standard treatment guidelines. Although there are risks such as minor discomfort from blood draws and scalp injections and/or a small risk of disease progression, the potential benefits include improved hair growth and a better understanding of CCCA treatments.

Research Team

Oyetewa Asempa, MD

Principal Investigator

Baylor College of Medicine

Assistant Professor of Dermatology

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+