Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia

Official title

Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia: A Randomized Clinical Trial

Overview

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.

Detailed description

Central centrifugal cicatricial alopecia (CCCA) is a common form of permanent hair loss that primarily affects Black women, with up to 20% of this population experiencing the condition. CCCA is characterized by progressive hair loss starting at the crown and spreading outward, often accompanied by symptoms such as burning, itching, and scalp pain. Current treatments focus on reducing inflammation using topical or injectable steroids and oral anti-inflammatory medications. However, these approaches frequently fail to stop hair loss or stimulate hair regrowth, and little is known about the disease's underlying mechanisms. Recent research suggests that CCCA is driven by significant fibrosis out of proportion to the initial inflammation, making it a chronic fibroproliferative disorder that may be similar to conditions like systemic sclerosis, keloids, and uterine fibroids. This scarring complicates treatment and contributes to the physical, emotional, and psychological burden that many Black women with CCCA experience.

Our research proposal aims to evaluate the use of platelet-rich plasma (PRP) injections as a novel therapeutic approach for CCCA. PRP is an autologous treatment in which a patient's blood is processed to concentrate platelets, which contain multiple growth factors and cytokines known to promote tissue regeneration and reduce inflammation and scarring. PRP has been used successfully in other conditions but has not been studied extensively for CCCA. This study will be the first randomized, placebo-controlled trial to assess the efficacy of PRP in treating CCCA in Black women. We hypothesize that PRP's anti-inflammatory and anti-fibrotic properties may slow the progression of the disease and, in some cases, induce hair regrowth. By comparing PRP with placebo injections, we aim to provide conclusive evidence on the treatment's effectiveness.

In addition to evaluating clinical outcomes, we will conduct a secondary experiment to measure growth factor levels in the PRP and platelet-poor plasma of CCCA patients and compare them with levels in women without scarring hair loss. This aspect of the study will provide insight into how specific growth factors may be influencing disease progression or treatment response. By understanding these growth factor profiles, we may be able to predict which patients are more likely to benefit from PRP treatment and potentially refine the approach to enhance its efficacy.

The impact of this study extends beyond CCCA treatment. Our research on growth factor profiles could lead to broader applications in managing other fibrotic skin conditions, such as keloids and systemic sclerosis. This project represents a significant step toward improving hair loss treatments for Black women, providing evidence-based care that takes into account the unique pathophysiology of CCCA. Ultimately, our findings could lead to more personalized treatment strategies, offering hope for improved outcomes and a better quality of life for patients suffering from this challenging condition.

Interventions

• Biological Platelet-Rich Plasma (PRP) Injections
  PRP will be injected into the affected scalp.
• Drug Saline
  Placebo saline solution will be injected into affected scalp.

Primary outcome measures

• Physician Global Assessment of Regrowth (PGARG) [Time frame: At each injection visit: week 0, week 4, week 8, and week 20 (treatment arm 2 and placebo arm 2 only), and three months and six months after final injection]

Secondary outcome measures (9)

• Change in hair counts [Time frame: Baseline and three and six months post final treatment.]
• Change in Central Hair Loss Grade stage [Time frame: Baseline and three and six months post final treatment.]
• Change in CCCA-QLI [Time frame: Baseline and three and six months post final treatment.]
• Change in C-CAT [Time frame: Baseline and three and six months post final treatment.]
• Change in qualitative histological findings at 3 follicular levels [Time frame: Baseline and six months post final treatment.]
• Change in quantitative histological findings at 3 follicular levels [Time frame: Baseline and six months post final treatment.]
• Change in C-TAS score [Time frame: Baseline and six months post final treatment]
• GF levels in plasma and PRP samples of CCCA patients will be compared between responders and non-responders to PRP therapy. [Time frame: Baseline and six months post final treatment.]
• Safety evaluations [Time frame: Baseline and six months post final treatment.]

Eligibility criteria

Inclusion criteria

• Female
• Minimum age of 18 years old
• Self-identification as person of African descent, including African, Afro-Caribbean, Afro-Latino, and/or African American
• Clinical diagnosis of mild to moderate CCCA located on the vertex or fronto-vertex scalp, and as defined by Central Hair Loss Grade stages 1B, 2B, and 3B

Exclusion criteria

• Intralesional or systemic anti-inflammatory medications (corticosteroids, tetracycline antibiotics, anti-malarials) or immunosuppressive drugs (cyclosporine, mycophenolate mofetil, methotrexate, azathioprine, janus kinase inhibitors) within 4 weeks of baseline visit
• Pregnant women
• Topical minoxidil, metformin, or retinoic acid for 4 weeks prior to baseline visit
• Severe or end-stage CCCA, Central Hair Loss Grade stage \>3B
• Thrombocytopenia (as defined by baseline platelet count \< 150,000 platelets per microliter of blood)
• Antiplatelet or platelet altering medications (such as but not limited to aspirin, NSAIDS, clopidogrel, ticagrelor, and prasugrel, cilostazol, and dipyridamole) within 4 weeks of baseline visit
• Diagnosis of other significant concomitant alopecia
• Clinically significant uncontrolled disease, malignancy, or major psychiatric illness requiring hospitalization (as determined by investigator)
• Subjects not willing to follow suggested hair care practices such as limiting/avoiding traction-associated styles

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Jamail Specialty Care Center — Houston

Publications

• Kyei A, Bergfeld WF, Piliang M, Summers P. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study. Arch Dermatol. 2011 Aug;147(8):909-14. doi: 10.1001/archdermatol.2011.66. Epub 2011 Apr 11. PMID 21482861
• Olsen EA, Callender V, McMichael A, Sperling L, Anstrom KJ, Shapiro J, Roberts J, Durden F, Whiting D, Bergfeld W. Central hair loss in African American women: incidence and potential risk factors. J Am Acad Dermatol. 2011 Feb;64(2):245-52. doi: 10.1016/j.jaad.2009.11.693. Epub 2010 Nov 13. PMID 21075478
• Jackson T, Sow Y, Dinkins J, Aguh C, Omueti Ayoade K, Barbosa V, Burgess C, Callender V, Cotsarelis G, Grimes P, Harvey V, Kindred C, Lester J, Lo Sicco K, Mayo T, McMichael A, Oboite M, Ogunleye T, Olsen E, Osei-Tutu A, Piliang M, Senna M, Shapiro J, Tosti A, Frey C, Adotama P, Taylor SC. Treatment for central centrifugal cicatricial alopecia-Delphi consensus recommendations. J Am Acad Dermatol. PMID 38341148
• Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794. PMID 33096812

Identifiers

NCT: NCT06998433 · H-55519

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗