Platelet Rich Plasma for Frontal Fibrosing Alopecia

NCT03335228 | Withdrawn DMC FDA Device

• 1 other identifier: DERM-2020-28608
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontal Fibrosing Alopecia

Keywords

platelet rich plasma, frontal fibrosing alopecia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• self-assessment using the Dermatology Quality Life Index

  Baseline to 3 years

Study Arms (1)

Eclipse Easy Spin for PRP Treatment

EXPERIMENTAL

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

Interventions

Eclipse Easy Spin for PRP DEVICE

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

Eclipse Easy Spin for PRP Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Maria Hordinsky, MD

  University of Minnesota Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Ronda Farah, MD

  University of Minnesota Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: November 7, 2017
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)