Platelet Rich Plasma for Frontal Fibrosing Alopecia

Assessment of the Safety and Efficacy of Intralesional Platelet Rich Plasma in Reducing Scalp Symptoms and Promoting Hair Growth in 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. 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.

Study Overview

• Status: Withdrawn
• Conditions: Frontal Fibrosing Alopecia
• Intervention / Treatment: Device: Eclipse Easy Spin for PRP

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eclipse Easy Spin for PRP Treatment; 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.

Device: Eclipse Easy Spin for PRP; Autologous platelet rich plasma is prepared from subject's blood with the Eclipse Easy Spin centrifuge and injected into affected areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the LPPAI score from baseline	Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe	Baseline to 3 years
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	Changes in hair growth from baseline to study completion using scalp photography hair growth in patients diagnosed with frontal fibrosing alopecia	Baseline to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-assessment using the Dermatology Quality Life Index	Subject self-assessment using the Dermatology Quality Life Index (DQLI)	Baseline to 3 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Maria Hordinsky, MD, University of Minnesota Department of Dermatology; Principal Investigator: Ronda Farah, MD, University of Minnesota Department of Dermatology

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: platelet rich plasma, frontal fibrosing alopecia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: DERM-2020-28608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes