ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06240351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Boni Elewski, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Boni Elewski, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

Frontal Fibrosing Alopecia