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

Last updated: May 12, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

4

Condition

Hair Loss

Alopecia

Treatment

Baricitinib 4 MG Oral Tablet

Clinical Study ID

NCT06240351
IRB-300009525
2026154
  • Ages 18-90
  • Female

Study 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

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 monthswithout an alternative medical cause and elevated follicle stimulating hormone inthe 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 priorto screening or at the screening visit.

  • Agree not to have a live vaccination during the study the exception is herpes zostervaccine

Exclusion

Exclusion Criteria:

  • Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half liveswhichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, orimmunosuppressant 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 studyparticipation

  • Previous treatment with an oral JAK inhibitor

  • Any condition in the opinion of the investigator which would interfere with thestudy 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

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Baricitinib 4 MG Oral Tablet
Phase: 4
Study Start date:
April 22, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

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