PRP for Frontal Fibrosing Alopecia

Overseen By Angela Wipf, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Anticoagulants, Corticosteroids, Chemotherapy, others

Disqualifiers: Immunosuppression, Autoimmune disorders, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 months

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called platelet rich plasma (PRP) to help people with frontal fibrosing alopecia, a type of hair loss. PRP is made from a person's own blood and injected into the scalp to promote hair growth and reduce symptoms. The study will last several months and includes multiple treatment visits and follow-ups. PRP therapy is a new procedure used to treat various types of hair loss by promoting hair growth.

Will I have to stop taking my current medications?

You will need to stop using over-the-counter and prescription hair/scalp products not supplied in the study, and avoid non-steroidal anti-inflammatory medications, aspirin, St. John's Wort, and high doses of Vitamin E for 4 weeks. If you are on oral treatments for frontal fibrosing alopecia or using intralesional or topical corticosteroids, you must have stopped these at least 3 months and 6 weeks ago, respectively.

What data supports the effectiveness of the treatment Platelet Rich Plasma (PRP) for Frontal Fibrosing Alopecia?

Research shows that Platelet Rich Plasma (PRP) has been beneficial in treating various types of hair loss, including androgenetic alopecia and alopecia areata. There is growing interest in its potential use for scarring types of hair loss, like frontal fibrosing alopecia, due to its regenerative properties. ^{1 2 3 4 5}

Is PRP generally safe for use in humans?

Platelet-rich plasma (PRP) has been used in treating hair loss conditions like androgenic alopecia and is considered safe, with studies reporting no major adverse reactions. ^{2 5 6 7 8}

How does the PRP treatment for frontal fibrosing alopecia differ from other treatments?

PRP (Platelet Rich Plasma) is unique because it uses a concentration of platelets from the patient's own blood to potentially stimulate hair growth and tissue regeneration, which is different from other treatments that may involve topical or oral medications. This approach is novel for frontal fibrosing alopecia, as there are no standard treatments specifically for this condition. ^{1 2 3 5 9}

Research Team

Maria K Hordinsky

Principal Investigator

University of Minnesota Department of Dermatology

Ronda Farah, MD

Principal Investigator

University of Minnesota Department of Dermatology

Eligibility Criteria

This trial is for adults with frontal fibrosing alopecia, who can consent and follow the study rules. They must not be pregnant or breastfeeding, avoid certain medications and supplements, use specific shampoo, and agree to contraception if applicable. People with scalp atrophy, severe allergies, bleeding disorders or on certain treatments are excluded.

Inclusion Criteria

I am 18 years old or older.

I am willing to use Head and Shoulders shampoo during the study.

I agree to use effective birth control during the study.

Exclusion Criteria

You have a tendency to develop raised or thick scars.

I am currently on medication that weakens my immune system.

I have had other scalp or hair conditions in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive intralesional platelet rich plasma injections once a month for 6 months

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

Long-term follow-up

Participants are assessed for changes in hair growth and quality of life over an extended period

3 years

Treatment Details

Interventions

• Platelet Rich Plasma

Trial Overview The trial tests platelet rich plasma (PRP) prepared using Eclipse Easy Spin centrifuge for treating frontal fibrosing alopecia. PRP will be injected into the affected scalp area to see if it reduces symptoms and promotes hair growth.

Participant Groups

Group I: Eclipse Easy Spin for PRP Treatment Experimental Treatment 1 Intervention

Assessing the safety and efficacy of platelet rich plasma for treating frontal fibrosing alopecia. This will be accomplished by the production of platelet rich plasma by the Eclipse Easy Spin centrifuge. Subjects will receive treatment once a month for 6 months. Platelet rich plasma will be administered via injections into the affected areas of the scalp.

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet Rich Plasma for:

• Facet-mediated lumbar low back pain
• Degenerative joint disease
• Chronic pain

Approved in European Union as Platelet Rich Plasma for:

• Orthopedic conditions
• Musculoskeletal disorders
• Pain management

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Platelet-rich plasma (PRP) is derived from a patient's own blood and contains a high concentration of platelets, which can enhance tissue regeneration.

PRP has shown effectiveness in treating various types of hair loss, including androgenic alopecia and alopecia areata, expanding its use beyond orthopedic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. Polster, H., Kagha, K., Luke, J.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Placebo-Controlled, Double-Blind, Half-Head Study to Assess the Efficacy of Platelet-Rich Plasma on the Treatment of Androgenetic Alopecia. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma and its Use for Cicatricial and Non-Cicatricial Alopecias: A Narrative Review. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic review: The platelet-rich plasma use in female androgenetic alopecia as effective autologous treatment of regenerative plastic surgery. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of autologous platelet-rich plasma therapy versus topical Minoxidil in men with moderate androgenetic alopecia: a randomized open-label trial. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma in treatment of androgenic alopecia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for Hair Restoration. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Activated 3X Platelet-Rich Plasma in the Treatment of Androgenic Alopecia. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Investigating the Safety and Efficacy of Platelet-Rich Plasma (PRP) Treatment for Female Androgenetic Alopecia: Review of the Literature. [2021]