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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03335228
Other study ID # DERM-2020-28608
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2025
Est. completion date September 2026

Study information

Verified date April 2024
Source University of Minnesota
Contact Angela Wipf, BS
Phone (612) 624-5721
Email derm@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date September 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Minnesota Department of Dermatology Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the LPPAI score from baseline Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe Baseline to 3 years
Primary 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 Baseline to 3 years
Secondary self-assessment using the Dermatology Quality Life Index Subject self-assessment using the Dermatology Quality Life Index (DQLI) Baseline to 3 years
See also
  Status Clinical Trial Phase
Completed NCT04409041 - Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia Phase 2
Completed NCT03630198 - Pain Outcomes Following Intralesional Corticosteroid Injections Phase 4
Enrolling by invitation NCT06202560 - Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study N/A
Not yet recruiting NCT02467101 - Study to Assess the Efficacy of Intralesional Corticosteroid on the Treatment of Frontal Fibrosing Alopecia N/A
Recruiting NCT03422640 - Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia Phase 4
Completed NCT03346668 - Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia Early Phase 1
Active, not recruiting NCT03082560 - Design and Validation of a New Assessment Tool for Lichen Planopilaris
Completed NCT04342091 - Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling N/A
Recruiting NCT06240351 - A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA) Phase 4
Completed NCT05332366 - A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia Phase 2