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Platelet Rich Plasma for Frontal Fibrosing Alopecia

Primary Purpose

Frontal Fibrosing Alopecia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eclipse Easy Spin for PRP
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontal Fibrosing Alopecia focused on measuring platelet rich plasma, frontal fibrosing alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eclipse Easy Spin for PRP Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in the LPPAI score from baseline
Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe
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

Secondary Outcome Measures

self-assessment using the Dermatology Quality Life Index
Subject self-assessment using the Dermatology Quality Life Index (DQLI)

Full Information

First Posted
July 27, 2017
Last Updated
June 22, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03335228
Brief Title
Platelet Rich Plasma for Frontal Fibrosing Alopecia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Fibrosing Alopecia
Keywords
platelet rich plasma, frontal fibrosing alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eclipse Easy Spin for PRP Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Eclipse Easy Spin for PRP
Intervention Description
Autologous platelet rich plasma is prepared from subject's blood with the Eclipse Easy Spin centrifuge and injected into affected areas.
Primary Outcome Measure Information:
Title
Changes in the LPPAI score from baseline
Description
Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe
Time Frame
Baseline to 3 years
Title
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
Description
Changes in hair growth from baseline to study completion using scalp photography hair growth in patients diagnosed with frontal fibrosing alopecia
Time Frame
Baseline to 3 years
Secondary Outcome Measure Information:
Title
self-assessment using the Dermatology Quality Life Index
Description
Subject self-assessment using the Dermatology Quality Life Index (DQLI)
Time Frame
Baseline to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Wipf, BS
Phone
(612) 624-5721
Email
derm@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra M Streifel, BA
Phone
(612) 624-5721
Email
derm@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota Department of Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronda Farah, MD
Organizational Affiliation
University of Minnesota Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Platelet Rich Plasma for Frontal Fibrosing Alopecia

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