Platelet Rich Plasma for Frontal Fibrosing Alopecia

April 20, 2025 updated by: University of Minnesota

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Angela Wipf, BS
  • Phone Number: (612) 624-5721
  • Email: derm@umn.edu

Study Contact Backup

  • Name: Alexandra M Streifel, BA
  • Phone Number: (612) 624-5721
  • Email: derm@umn.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the LPPAI score from baseline
Time Frame: Baseline to 3 years
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
Time Frame: 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
Baseline to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
self-assessment using the Dermatology Quality Life Index
Time Frame: Baseline to 3 years
Subject self-assessment using the Dermatology Quality Life Index (DQLI)
Baseline to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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