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Transcriptomic Skin Analysis for Atopic Dermatitis (LEADS Trial)
LEADS Trial Summary
This trial will help researchers understand the different ways atopic dermatitis manifests, in order to better tailor treatments.
LEADS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEADS 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 2021 Phase 4 trial • 188 Patients • NCT04033367LEADS Trial Design
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Who is running the clinical trial?
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- Parent or guardian must be able to understand and complete study-related questionnaires.I only have Atopic Dermatitis and no other skin conditions affecting my skin's outer layer.You have a history of heavy drinking or drug abuse within the past 2 years.I have never had keloids form after an injury or surgery.You have other medical issues or conditions that the researcher thinks might make it risky for you to participate in the study, that could make it hard for you to follow the study requirements, or could affect the study results. This includes having a known allergy to certain anesthetics, bleeding disorders, taking blood thinning medication, or having other conditions that make having a biopsy unwise.I haven't been in a drug trial or taken experimental drugs for the longer of 8 weeks or 5 half-lives before my first visit.I have not used phototherapy or visited a tanning booth in the last 4 weeks.I have not taken a bleach bath in the week before my first visit.I have not used a chlorinated hot tub in the week before my first check-up.I can start using certain moisturizers during the study if I haven't before.I weigh less than 15 kg.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.I will continue my asthma medication throughout the study.I haven't taken any cell-depleting drugs, like rituximab, in the last 6 months or until my lymphocyte counts returned to normal.I have been diagnosed with HIV.I have a history of non-cancerous conditions that affect my lymph nodes.I agree to use approved birth control methods during the study.I agree to regularly apply a specific moisturizer provided by the study.I haven't had a parasitic infection (other than vaginal trichomoniasis) in the last year and am not at high risk for one.I am not planning any major surgeries that could interfere with the study.I have not taken antibiotics or antivirals for an infection in the last 4 weeks.I haven't taken any immune system altering drugs in the last 4 weeks.I agree to use approved birth control methods during the study.I agree to regularly apply a specific moisturizer provided by the study.I have asthma and needed steroids recently or take a high dose of inhaled steroids.I have not had a live vaccine in the last 6 weeks and won't get one during the study.I haven't taken specific immune treatments in the last 16 weeks.I have skin lesions large enough for testing and have never used Dupilumab.I have been on dupilumab for at least 4 months.I am not pregnant, as confirmed by tests at my first and second visits.I haven't taken any biologic drugs for at least 16 weeks or 5 half-lives, whichever is longer.I agree not to use steroid creams on a specific area until after Day 7.I have had chronic atopic dermatitis for at least 1 year.I am not pregnant, as confirmed by tests at my first and second visits.I will continue my asthma medication throughout the study.You have had a severe and life-threatening reaction to medical tape or adhesives in the past.You are allergic to any of the ingredients in the study treatments, including Vanicream (TM), hydrocortisone, triamcinolone, or dupilumab.You have an eye condition that could put you at risk during the study, such as a history of herpes keratitis, Sjogren's Syndrome, Keratoconjunctivitis Sicca or Dry Eye Syndrome that requires daily use of additional lubrication or the regular use of ocular corticosteroids or cyclosporine.
- Group 1: Dupilumab-naïve atopic dermatitis participants
- Group 2: Experienced Dupilumab atopic dermatitis participants
- Group 3: Non-atopic dermatitis participants
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have signed up for the experiment thus far?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this experiment is actively seeking out patients, which commenced its recruitment process on November 21st 2022 and was recently revised on the 30th of the same month. Approximately 600 participants are needed from 10 distinct healthcare facilities."
Are any additional participants being admitted to this clinical experiment?
"As indicated on clinicaltrials.gov, this medical trial is open for participant recruitment since November 21st 2022 and was most recently revised on the 30th of that same month."
In what locales is this research endeavor being conducted?
"This clinical trial is available at Cincinnati Children's Hospital Medical Center: Asthma Center in Ohio, University of California, San Diego: Dermatology Clinical Trials Unit in La Jolla and National Jewish Health: Division of Pediatric Allergy and Clinical Immunology in Denver as well as 10 additional medical establishments."
Has the Dupilumab drug been ratified by the FDA?
"There is ample evidence supporting the safety of dupilumab, so it achieved a rating of 3 on our team's scale. This medication has already been approved for clinical use."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology: < 48 hours
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