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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06998433
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Central Centrifugal Cicatricial Alopecia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm 1
    In treatment arm 1, participants will receive a total of three PRP injections spaced four weeks apart (Week 0, Week 4, Week 8).
  • Experimental: Treatment arm 2
    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).
  • Placebo Comparator: Placebo arm 1
    In Placebo arm 1, participants will receive a total of three saline injections spaced four weeks apart (Week 0, Week 4, Week 8).
  • Placebo Comparator: Placebo arm 2
    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).

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jamail Specialty Care CenterHoustonTexas77030-

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By research site
Jamail Specialty Care Center· Houston, TX

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