A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
Purpose
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
Condition
- Frontal Fibrosing Alopecia
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Baricitinib |
All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham