Clinical trial NCT06240351: A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
Official title: A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Frontal Fibrosing Alopecia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2024-02-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 30% Change in Lichen Planopilaris Activity (LPPAI) Scores
timeFrame: From baseline to week 12, 24, and 36
Secondary outcomes:
measure: Improvement in Physician Global Assessment (PGA)
timeFrame: From baseline to week 12, 24, and 36
measure: Change in inflammation on histology as seen on scalp biopsy
timeFrame: From baseline to week 12,24, and 36
measure: Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale
timeFrame: From baseline to week 12,24, and 36
measure: Improvement in Eyebrow Assessment
timeFrame: From baseline to week 12,24, and 36
measure: Improvement in Visual Analog Scale (VAS)
timeFrame: From baseline to week 12,24, and 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Boni Elewski, MD
role: PRINCIPAL_INVESTIGATOR
References: