Frontal Fibrosing AlopeciaPhase 4NCT06240351
A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
A Phase 4 study testing Baricitinib 4 MG Oral Tablet in people with Frontal Fibrosing Alopecia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Baricitinib 4 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 16 Sep 2026
- Phase
- Phase 4
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at least 18 years of age, and able to provide informed consent
- Females who are post-menopausal defined, as not have menses for at least 12 months without an alternative medical cause and elevated follicle stimulating hormone in the postmenopausal range as measured during screening
- Have active FFA that has been diagnosed on or prior to screening visit.
- Have LPPAI score equal to or greater than 5 at screening.
- Have evidence of eyebrow loss at baseline
- Have evidence of hairline recession at baseline
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- Have classic presentation with frontal loss of scalp hair
- Negative screening for tuberculosis (Quantiferon Gold, T-spot) within 3 months prior to screening or at the screening visit.
- Agree not to have a live vaccination during the study the exception is herpes zoster vaccine
Who cannot join
- Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half lives whichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, or immunosuppressant medications, such as mycophenolate mofetil).
- Dutasteride within the last 6 months
- Have a LPPAI score less than 5 at screening
- Immunocompromised and with risk factors concerning to investigator for study participation
- Previous treatment with an oral JAK inhibitor
- Any condition in the opinion of the investigator which would interfere with the study assessments or procedure
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- Subject is pregnant or breast feeding
- Surgical intervention including face lifts and micro-blading on the treatment areas
- Any intervention (facelifts micro blading) that could affect the treatment areas (i.e. scalp and eyebrows)
- Laser or phototherapy intervention on the treatment areas
- Have evidence of active TB or latent TB
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Baricitinib 4 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MG Oral TabletDrug
Also called Olumiant
Baricitinib is a Janus kinase (JAK) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks. Receives: Drug: Baricitinib 4 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% Change in Lichen Planopilaris Activity (LPPAI) Scores
Percentage of patients achieving 30% change in LPPAI scores. LPPAI is a numeric scale that includes key signs and symptoms of FFA and allows for statistical comparison of disease activity. It captures patient reported symptoms (pruritus, pain, burning), clinical signs (erythema, perifollicular erythema, and scale), and other disease activity features (anagen pull and spreading). The total score distributes 30% weight to symptoms, 30% to signs, 25% to anagen pull, and 15% to spreading. The scale then ranges from 0-10 where 0 is no disease and 10 is worst disease.
Measured: From baseline to week 12, 24, and 36
Secondary outcomes (5)
Improvement in Physician Global Assessment (PGA)
Effectiveness of Baricitinib on improvement in Patient Global Assessment.This assessment is a scale from 0 to 4. 0 means clear skin while 4 means severe disease.
Measured: From baseline to week 12, 24, and 36
Change in inflammation on histology as seen on scalp biopsy
Effectiveness of Baricitinib on change of inflammation results on histology exam as seen on scalp biopsy. Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy (which correlates with severity of inflammatory changes on pathology).
Measured: From baseline to week 12,24, and 36
Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale
Effectiveness of Baricitinib on the improvement in trichoscopic grading of peripheral casts (scales). Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy by the Tosti Scale. This is a 3 grade measure with Grade 1 being minimum scaling while Grade 3 is maximum scaling.
Measured: From baseline to week 12,24, and 36
Improvement in Eyebrow Assessment
Effectiveness of Baricitinib on the improvement of the eyebrow assessment. This is a survey for patients to answer. Answers range from 0 to 3. Answers of 0 mean "I have full eyebrows on each side" while answers of 3 mean " I have no or barely any eyebrow hairs.
Measured: From baseline to week 12,24, and 36
Improvement in Visual Analog Scale (VAS)
Effectiveness of Baricitinib on the improvement of the Visual Analog Scale. This is a 10-point visual scale to rate whether the patient's FFA seems to be worse or resolved.
Measured: From baseline to week 12,24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start22 Apr 2024
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
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 Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Boni Elewski, University of Alabama at Birmingham
- Investigators
- Boni Elewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240351
- Sponsor's protocol ID
- IRB-300009525
- Other IDs
- 2026154
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
- ClinicalTrials.gov ID
- NCT06240351
- Acronym / sponsor ID
- IRB-300009525
- Conditions
- Frontal Fibrosing Alopecia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 5 Feb 2024 (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 goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib 4 MG Oral TabletAll patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female at least 18 years of age, and able to provide informed consent
- Females who are post-menopausal defined, as not have menses for at least 12 months without an alternative medical cause and elevated follicle stimulating hormone in the postmenopausal range as measured during screening
- Have active FFA that has been diagnosed on or prior to screening visit.
- Have LPPAI score equal to or greater than 5 at screening.
- Have evidence of eyebrow loss at baseline
Key exclusion criteria (11 listed)
- Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half lives whichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, or immunosuppressant medications, such as mycophenolate mofetil).
- Dutasteride within the last 6 months
- Have a LPPAI score less than 5 at screening
- Immunocompromised and with risk factors concerning to investigator for study participation
- Previous treatment with an oral JAK inhibitor
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 |
|---|---|---|
| Baricitinib 4 MG Oral TabletAlso: OlumiantBaricitinib is a Janus kinase (JAK) inhibitor | Drug | Baricitinib |
Primary outcome
30% Change in Lichen Planopilaris Activity (LPPAI) Scores
Time frame: From baseline to week 12, 24, and 36
Percentage of patients achieving 30% change in LPPAI scores. LPPAI is a numeric scale that includes key signs and symptoms of FFA and allows for statistical comparison of disease activity. It captures patient reported symptoms (pruritus, pain, burning), clinical signs (erythema, perifollicular erythema, and scale), and other disease activity features (anagen pull and spreading). The total score distributes 30% weight to symptoms, 30% to signs, 25% to anagen pull, and 15% to spreading. The scale then ranges from 0-10 where 0 is no disease and 10 is worst disease.
5 secondary outcomes
Improvement in Physician Global Assessment (PGA)
Time frame: From baseline to week 12, 24, and 36
Change in inflammation on histology as seen on scalp biopsy
Time frame: From baseline to week 12,24, and 36
Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale
Time frame: From baseline to week 12,24, and 36
Improvement in Eyebrow Assessment
Time frame: From baseline to week 12,24, and 36
Improvement in Visual Analog Scale (VAS)
Time frame: From baseline to week 12,24, and 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
Boni Elewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baricitinib 4 MG Oral Tablet in people with Frontal Fibrosing Alopecia, run by University of Alabama at Birmingham 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 11 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: finished, as of the sponsor's last update on 30 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30% Change in Lichen Planopilaris Activity (LPPAI) Scores (time frame: From baseline to week 12, 24, and 36). 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 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.