Platelet Rich Plasma for Frontal Fibrosing Alopecia

The primary objective of this study is to assess the efficacy and safety of platelet rich
plasma in reducing scalp symptoms and promoting hair growth in patients diagnosed with
frontal fibrosing alopecia. The secondary objective of this study is subject self-assessment
through the Dermatology Quality Life Index (DQLI) and Hair-Growth Assessment (HGA) as well as
investigator-assessment from baseline. Platelet rich plasma is an autologous blood product,
and platelet rich plasma will be administered intralesionally for this study. The platelet
rich plasma used for this study will be prepared using the Eclipse Easy Spin centrifuge. The
duration of this study for participants is 8 months, including an initial screening visit, 6
monthly treatment visits, and a follow-up visit. Subjects eligible for this study are those
diagnosed with frontal-fibrosing alopecia via biopsy and clinical assessment.

Inclusion Criteria:

- Males and females, ages 18 and older

- Diagnosed by a board-certified dermatologist with frontal fibrosing alopecia

- Scalp biopsy consistent with frontal fibrosing alopecia diagnosis

- Willing to use Head and Shoulders shampoo for the scalp while in study

- Willing to abstain from over the counter and prescription hair/scalp products other
than those supplied in the study

- Willing to abstain from the use of non-steroidal anti-inflammatory medications,
aspirin, St, John's Wart, and high doses of Vitamin E supplementation for 4 weeks

- Subjects must be capable of giving informed consent

- Stated willingness to comply with all study procedures and be available for the
duration of the study

- For women with reproductive potential, a willingness to use methods of contraception
that will prevent the subject from becoming pregnant during the study. Adequate
contraception methods include hormonal methods used for two or more menstrual cycles
before screening (eg. oral contraceptive pills, contraceptive patch, or contraceptive
vaginal ring), barrier methods (eg, contraceptive sponge, diaphragm in conjunction
with contraceptive foam or jelly, or condom in conjunction with contraceptive foam or
jelly), intrauterine methods (IUD), sterilization (eg, tubal ligation or a monogamous
relationship with a vasectomized partner) and abstinence

Exclusion Criteria:

- Current immunosuppression

- Oral treatment of FFA within the last 3 months (such as hydroxycholroquine,
doxycycline, minocycline, acitretin, mycophenolate mofetil, cyclosporine, prednisone,
rituximab, and pioglitazone etc.)

- History of other scalp/hair disease

- Current chemotherapy or radiation

- Propensity for keloids or hypertrophic scarring

- Autoimmune disorders

- Hematologic disorder or bleeding disorder

- Platelet dysfunction

- Use of anticoagulation therapy

- Active malignancy

- Use of intralesional or topical corticosteroids in the last 6 weeks

- Scalp atrophy

- Pregnant and/or breastfeeding

- Allergy or intolerance to triamcinolone

- Severe allergies manifested by a history of anaphylaxis, or history or presence of
multiple severe allergies

- Medical problems including HIV, connective tissue disorder, PCOS, or untreated thyroid
disease

- Any psychiatric or medical condition that in the opinion of the investigator will
interfere with patient's ability to participate in the trial

- Current use of tanning beds or any active tanning

- Planned upcoming pregnancy