Evaluating Baricitinib for treating Frontal Fibrosing Alopecia
A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
This study is testing whether the oral medication Baricitinib can help post-menopausal women with frontal fibrosing alopecia improve their hair loss and related symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | Baricitinib |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06240351 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of Baricitinib, an oral medication, in treating frontal fibrosing alopecia (FFA) in post-menopausal women. Participants will be evaluated based on specific criteria, including the presence of active FFA and certain clinical features such as eyebrow loss and hairline recession. The study will involve administering Baricitinib and monitoring its impact on the condition over a defined period. The trial is designed to provide insights into the potential benefits of this treatment for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are post-menopausal women aged 18 and older with a confirmed diagnosis of active frontal fibrosing alopecia.
Not a fit: Patients currently undergoing systemic treatments for FFA or those with other underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve hair regrowth and overall quality of life for patients suffering from frontal fibrosing alopecia.
How similar studies have performed: While there is limited data on Baricitinib specifically for FFA, similar studies on its use for other autoimmune conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Boni Elewski, MD — University of Alabama at Birmingham
- Study coordinator: Ralee' Bunt, MSPH
- Email: erikabunt@uabmc.edu
- Phone: 205-502-9960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.