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Platelet Rich Plasma for Frontal Fibrosing Alopecia

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ClinicalTrials.gov Identifier: NCT03335228
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Frontal Fibrosing Alopecia Device: Eclipse Easy Spin for PRP Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Safety and Efficacy of Intralesional Platelet Rich Plasma in Reducing Scalp Symptoms and Promoting Hair Growth in Frontal Fibrosing Alopecia
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. self-assessment using the Dermatology Quality Life Index [ Time Frame: Baseline to 3 years ]
    Subject self-assessment using the Dermatology Quality Life Index (DQLI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335228


Contacts
Contact: Angela Wipf, BS (612) 624-5721 derm@umn.edu
Contact: Alexandra M Streifel, BA (612) 624-5721 derm@umn.edu

Locations
United States, Minnesota
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota Department of Dermatology
Principal Investigator: Ronda Farah, MD University of Minnesota Department of Dermatology

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03335228     History of Changes
Other Study ID Numbers: PRP for FFA
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
platelet rich plasma, frontal fibrosing alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical