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

IRB-300009525

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

2024-04-22

2025-04-30

2025-12-31

Recruiting

Early phase I

15

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-06-05