Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaylor College of Medicine
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet-Rich Plasma (PRP) Injections
Biological/VaccinePRP will be injected into the affected scalp.
Saline
DrugPlacebo saline solution will be injected into affected scalp.
Treatment groups
56 Participants
are divided into 4 treatment groupsGroup A: Treatment arm 1Experimental treatment 1 intervention
Group B: Treatment arm 2Experimental treatment 1 intervention
Group C: Placebo arm 1Placebo comparator 1 intervention
Group D: Placebo arm 2Placebo comparator 1 intervention
Trial outcomes
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.
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 injectionSecondary outcomes
1
Change in hair counts
Change in hair counts at study end from baseline, including hair density, hair shaft diameter, vellus hair ratio and single hair follicle unit ratio counted digitally using the Canfield Metrix system
Time frame
Baseline and three and six months post final treatment.2
Change in Central Hair Loss Grade stage
Change in Central Hair Loss Grade stage at study end compared to baseline: Degree of severity of hair loss is graded on a 6-point scale: 0: no hair loss, 1-2: mild hair loss, 3-5: more severe hair loss.
Time frame
Baseline and three and six months post final treatment.3
Change in CCCA-QLI
Change in CCCA-QLI: Assessment of patients' perception of hair loss and how it relates to their quality of life.
Time frame
Baseline and three and six months post final treatment.4
Change in C-CAT
Change in C-CAT: Symptom severity questionnaire consisting of numeric ratings of severity of disease progression, pain, pruritus, erythema, and scalp resistance. Values range from 0 (absent) to 2 (moderate-severe) for each symptom. A total score of 0 denotes quiescent disease, less than or equal to 2: mild disease; 3-5: moderate disease; greater than or equal to 6: severe disease activity.
Time frame
Baseline and three and six months post final treatment.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: