University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT06240351
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
This study is active but is not currently recruiting participants.
Notify Me18 year–90 year
Female
Interventional
Phase 4
Birmingham, Alabama, 35233, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Baricitinib is a Janus kinase (JAK) inhibitor
Other names: Olumiant
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.
Time frame: From baseline to week 12, 24, and 36
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.
Time frame: From baseline to week 12,24, and 36
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).
Time frame: From baseline to week 12,24, and 36
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.
Time frame: From baseline to week 12,24, and 36
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.
Time frame: From baseline to week 12,24, and 36
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.
University of Alabama at Birmingham
Other
A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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