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

NCT06998433 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: H-55519
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

CCCA; scarring alopecia; alopecia; hair loss; PRP; platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• Physician Global Assessment of Regrowth (PGARG)

  Physician Global Assessment of Regrowth (PGARG): The average of scores assessed by 2 blinded investigators using comparison of global photography at study end (9 months after initial injection) to photographs from baseline visit. Value of 0 indicates no regrowth; 1, 25% regrowth; 2, 25%-49% regrowth; 3, 50%-74% regrowth; 4, 75%-99% regrowth; 5, 100% regrowth. Average scores between 0.1 and 0.5 will be rounded down to zero. Scores between 0.6 and 0.9 will be rounded up to one.

  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 Outcomes (9)

• Change in hair counts

  Baseline and three and six months post final treatment.

• Change in Central Hair Loss Grade stage

  Baseline and three and six months post final treatment.

• Change in CCCA-QLI

  Baseline and three and six months post final treatment.

• Change in C-CAT

  Baseline and three and six months post final treatment.

• Change in qualitative histological findings at 3 follicular levels

  Baseline and six months post final treatment.

Study Arms (4)

Treatment arm 1

EXPERIMENTAL

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

Biological: Platelet-Rich Plasma (PRP) Injections

Treatment arm 2

EXPERIMENTAL

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).

Biological: Platelet-Rich Plasma (PRP) Injections

Placebo arm 1

PLACEBO COMPARATOR

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

Drug: Saline

Placebo arm 2

PLACEBO COMPARATOR

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).

Drug: Saline

Interventions

Platelet-Rich Plasma (PRP) Injections BIOLOGICAL

PRP will be injected into the affected scalp.

Treatment arm 1; Treatment arm 2

Saline DRUG

Placebo saline solution will be injected into affected scalp.

Placebo arm 1; Placebo arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Jamail Specialty Care Center

Houston, Texas, 77030, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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. 2024 Jun;90(6):1182-1189. doi: 10.1016/j.jaad.2023.12.073. Epub 2024 Feb 9.

  PMID: 38341148 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Oyetewa Asempa, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Assistant Professor of Dermatology

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chidimma Okwara, MD

CONTACT

281 845 9847; chidimma.okwara@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study participants and investigators will be blinded to randomization results. The investigators who assess the primary endpoint will be blinded and independent of the investigators who administer the study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: May 31, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)