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

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 4

Conditions: Frontal Fibrosing Alopecia

Treatments: Drug: Baricitinib 4 MG Oral Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06240351

2026154 (Other Identifier)

IRB-300009525

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Baricitinib

Experimental group

Description:

All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks.

Treatment:

Drug: Baricitinib 4 MG Oral Tablet