Platelet Rich Plasma for Frontal Fibrosing Alopecia

Not Applicable

Not yet recruiting

Brief Summary: 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. 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Eclipse Easy Spin for PRP Treatment	Eclipse Easy Spin for PRP	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.

Primary Outcome Measures

Name	Time	Method
Changes in the LPPAI score from baseline	Baseline to 3 years	Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe
Changes in the hair growth from baseline to the completion of the study • Change in hair growth from baseline to study completion via investigator assessment of scalp photography	Baseline to 3 years	Changes in hair growth from baseline to study completion using scalp photography hair growth in patients diagnosed with frontal fibrosing alopecia

Secondary Outcome Measures

Name	Time	Method
self-assessment using the Dermatology Quality Life Index	Baseline to 3 years	Subject self-assessment using the Dermatology Quality Life Index (DQLI)

Locations (1): University of Minnesota Department of Dermatology
🇺🇸
Minneapolis, Minnesota, United States