A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)

Running, not enrolling · Phase 4

Conditions studied: Frontal Fibrosing Alopecia

In brief

The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).

Key facts

Study ID

NCT06240351

Run by

University of Alabama at Birmingham

People needed

15

Starts

2024-04-22

Expected to finish

2027-09-30

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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