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Baricitinib for Pediatric Hair Loss (BRAVE-AA-PEDS Trial)
BRAVE-AA-PEDS Trial Summary
This trial will determine the effectiveness and safety of Baricitinib to treat hair loss in children 6-18 years old.
BRAVE-AA-PEDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRAVE-AA-PEDS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 1307 Patients • NCT01710358BRAVE-AA-PEDS Trial Design
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Who is running the clinical trial?
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- I am not bedridden and can take care of myself.I have had severe alopecia areata for less than 8 years or have seen hair regrowth in the last 8 years.I have had severe hair loss for at least a year.I do not have any serious health issues that could risk my participation.I have tried at least one treatment for alopecia areata without success.My blood pressure is under control.I have had severe hair loss for at least a year.My hair loss is not mainly from all over my scalp.I do not have any other hair loss conditions besides alopecia areata.I have had severe alopecia areata for 8+ years but have seen some hair regrowth.I am between 12 and 18 years old, or between 6 and 12 years old.I haven't had major surgery in the last 8 weeks and don't need any during the study.I have had an AA episode for at least 6 months.I was diagnosed over a year ago.You have been experiencing ongoing episodes of AA (a type of medical condition) for at least 6 months.You have received counseling in the past for issues related to alcohol addiction.Your SALT score, which measures the severity of a skin condition called psoriasis, is 50% or higher at the time of screening and baseline.I have tried at least one treatment for alopecia areata without success.
- Group 1: Placebo
- Group 2: Baricitinib Low Dose
- Group 3: Baricitinib High Dose
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do individuals over the age of 35 qualify to participate in this medical research?
"Participants that wish to be part of this trial must fall between 6 and 17 years of age."
How many institutions are overseeing this trial?
"This trial has 4 currently active sites, including Total Skin and Beauty Dermatology Center in Birmingham, Clarkston Skin Research in Clarkston, Texas Dermatology and Laser Specialists in San Antonio. There are also other locations that have been approved to participate."
Has the highest dose of Baricitinib received approval from the Food and Drug Administration?
"Based on the Phase 3 trial results, there is sufficient evidence to assign a score of 3 out of 3 for Baricitinib High Dose's safety profile."
Are there any current opportunities to participate in this clinical experiment?
"The clinical trial data available on clinicaltrials.gov does not indicate that this particular study is actively recruiting patients at the moment; it was first posted on February 28th 2023 and last edited about two weeks later. However, there are currently 128 other trials across various medical areas looking for candidates to participate in their research."
What qualifications are needed for an individual to partake in this clinical trial?
"This research project seeks to enrol 595 alopecia patients, aged 6-17 years old. Eligible participants must have experienced severe AA for more than a year, current hair loss covering 50% of the scalp or higher according to SALT score, failed treatment with topical solutions and/or other treatments previously attempted, participated in psychological counselling related to their condition, and have had an episode of severe AA that has lasted less than 8 years (individuals who have suffered from it for 8+ may still be eligible if regrowth was observed over this period)."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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