Central Centrifugal Cicatricial AlopeciaPhase 4NCT06998433
Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia
A Phase 4 study testing Platelet-Rich Plasma (PRP) Injections and Saline in people with Central Centrifugal Cicatricial Alopecia, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia
- What is being tested?
- Platelet-Rich Plasma (PRP) Injections and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia: A Randomized Clinical 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.
Read more
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.
Read the 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.
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Being tested
- Platelet-Rich Plasma (PRP) Injections, Saline
- Keywords
- CCCA, scarring alopecia, alopecia, hair loss, PRP, platelet rich plasma
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) InjectionsBiological
PRP will be injected into the affected scalp.
SalineDrug
Placebo saline solution will be injected into affected scalp.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Baseline and three and six months post final treatment.
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.
Measured: Baseline and three and six months post final treatment.
Change in CCCA-QLI
Change in CCCA-QLI: Assessment of patients' perception of hair loss and how it relates to their quality of life.
Measured: Baseline and three and six months post final treatment.
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.
Measured: Baseline and three and six months post final treatment.
Change in qualitative histological findings at 3 follicular levels
Measured: Baseline and six months post final treatment.
Change in quantitative histological findings at 3 follicular levels
Measured: Baseline and six months post final treatment.
Change in C-TAS score
Measured: 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.
Measured: Baseline and six months post final treatment.
Safety evaluations
Safety evaluations, including assessment of adverse events (AEs) such as erythema, worsening pruritus, worsening burning/stinging, scaling, and pain. Investigators will rate AEs as mild, moderate, or severe. Safety evaluations will be compared between treatment and placebo arms.
Measured: Baseline and six months post final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start30 Sep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oyetewa Boluwatito Asempa, Baylor College of Medicine
- Investigators
- Oyetewa Asempa, MD, Principal investigator, Baylor College of MedicineAssistant Professor of Dermatology, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998433
- Sponsor's protocol ID
- H-55519
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21482861Olsen 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.
PubMed 21075478Jackson 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.
PubMed 38341148Everts 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.
PubMed 33096812
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06998433
- Acronym / sponsor ID
- H-55519
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Keywords
- CCCA, scarring alopecia, alopecia, hair loss, PRP, platelet rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Experimental | Biological: Platelet-Rich Plasma (PRP) InjectionsIn treatment arm 1, participants will receive a total of three PRP injections spaced four weeks apart (Week 0, Week 4, Week 8). |
| Treatment arm 2 | Experimental | Biological: Platelet-Rich Plasma (PRP) InjectionsIn 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 arm 1 | Placebo comparator | Drug: SalineIn Placebo arm 1, participants will receive a total of three saline injections spaced four weeks apart (Week 0, Week 4, Week 8). |
| Placebo arm 2 | Placebo comparator | Drug: SalineIn 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Plasma (PRP) InjectionsPRP will be injected into the affected scalp. | Biological | Treatment arm 1, Treatment arm 2 |
| SalinePlacebo saline solution will be injected into affected scalp. | Drug | Placebo arm 1, Placebo arm 2 |
Primary outcome
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
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 21482861Kyei 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.
- Background: PubMed 21075478Olsen 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.
- Background: PubMed 38341148Jackson 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.
- Background: PubMed 33096812Everts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oyetewa Asempa, MD principal investigator
Baylor College of Medicine
Assistant Professor of Dermatology principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-Rich Plasma (PRP) Injections and Saline in people with Central Centrifugal Cicatricial Alopecia, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chidimma Okwara, MD (281 845 9847, chidimma.okwara@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998433, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.