Platelet Rich Plasma for Frontal Fibrosing Alopecia

NCT ID: NCT03335228

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-09-30

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.

Conditions

Frontal Fibrosing Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Eclipse Easy Spin for PRP

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Department of Dermatology

Ronda Farah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Department of Dermatology

Locations

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

DERM-2020-28608

Identifier Type: -

Identifier Source: org_study_id