Clinical trial NCT03335228: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Frontal Fibrosing Alopecia
Keywords: platelet rich plasma, frontal fibrosing alopecia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the LPPAI score from baseline
timeFrame: Baseline to 3 years
measure: 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
timeFrame: Baseline to 3 years
Secondary outcomes:
measure: self-assessment using the Dermatology Quality Life Index
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Dermatology
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota Department of Dermatology
name: Ronda Farah, MD
role: PRINCIPAL_INVESTIGATOR
References: