A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing … (NCT06240351) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
United States15 participantsStarted 2024-04-22
Plain-language summary
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
Who can participate
Age range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
30% Change in Lichen Planopilaris Activity (LPPAI) Scores