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

Recruiting
18 - 90 years of age
Female
Phase 4

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Overview

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

Eligibility

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 details

Frontal Fibrosing Alopecia

NCT06240351

University of Alabama at Birmingham

9 June 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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