Frontal Fibrosing AlopeciaNCT03335228
Platelet Rich Plasma for Frontal Fibrosing Alopecia
A study testing Eclipse Easy Spin for PRP in people with Frontal Fibrosing Alopecia, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Eclipse Easy Spin for PRP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455
About this study
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
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.
Read the 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.
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Eclipse Easy Spin for PRP
- Keywords
- platelet rich plasma, frontal fibrosing alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eclipse Easy Spin for PRPDevice
Autologous platelet rich plasma is prepared from subject's blood with the Eclipse Easy Spin centrifuge and injected into affected areas.
| Study group | Role | What they receive |
|---|---|---|
| Eclipse Easy Spin for PRP Treatment | Experimental | 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. Receives: Device: Eclipse Easy Spin for PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the LPPAI score from baseline
Changes in LPPAI (LICHEN PLANOPILARIS ACTIVITY INDEX) Scale of of 0-4 0= None 4=Severe
Measured: 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
Changes in hair growth from baseline to study completion using scalp photography hair growth in patients diagnosed with frontal fibrosing alopecia
Measured: Baseline to 3 years
Secondary outcomes (1)
self-assessment using the Dermatology Quality Life Index
Subject self-assessment using the Dermatology Quality Life Index (DQLI)
Measured: Baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontal Fibrosing AlopeciaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of Minnesota Department of DermatologyRonda Farah, MD, Principal investigator, University of Minnesota Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335228
- Sponsor's protocol ID
- DERM-2020-28608
- Status last verified
- Apr 2025
- First submitted
- 27 Jul 2017
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03335228
- Acronym / sponsor ID
- DERM-2020-28608
- Conditions
- Frontal Fibrosing Alopecia
- Keywords
- platelet rich plasma, frontal fibrosing alopecia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eclipse Easy Spin for PRP Treatment | Experimental | Device: Eclipse Easy Spin for PRPAssessing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eclipse Easy Spin for PRPAutologous platelet rich plasma is prepared from subject's blood with the Eclipse Easy Spin centrifuge and injected into affected areas. | Device | Eclipse Easy Spin for PRP Treatment |
Primary outcome
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
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
1 secondary outcome
self-assessment using the Dermatology Quality Life Index
Time frame: Baseline to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Frontal Fibrosing Alopecia
Not yet recruitingPhase 2
Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
Recruiting
Facial Papules in Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
RecruitingPhase 2
Deucravacitinib in the Treatment of Cicatricial Alopecias
Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
Not yet recruitingObservational study
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
Frontal Fibrosing Alopecia, Cicatricial Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD principal investigator
University of Minnesota Department of Dermatology
Ronda Farah, MD principal investigator
University of Minnesota Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eclipse Easy Spin for PRP in people with Frontal Fibrosing Alopecia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the LPPAI score from baseline (time frame: Baseline to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.