Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: National Jewish Health
Location: 1400 Jackson Street, Denver, Colorado 80206
Lead Researcher: Donald Y M Leung, Ph.D., MD
IRB: This study has been reviewed and approved by the BRANY (Biomedical Research Alliance of New York) Institutional Review Board
About the Study
Approximately 1 in 10 individuals suffer from atopic dermatitis (AD), a chronic skin condition marked by inflammation and itchiness. Despite available treatments, many patients continue to struggle with the disease’s severity and finding effective relief. Emerging research highlights the pivotal role of immune and epidermal anomalies in AD.
This study, being conducted by National Jewish Health, aims to delve deeper into these defects, aspiring to craft precision medicine strategies tailored to those most burdened by AD. By identifying biomarkers for patients resistant to conventional steroids or unresponsive to treatments like Dupilumab, we can unlock new understandings of what drives AD severity and treatment outcomes. Join us in pioneering the journey towards more personalized and effective treatments for AD, potentially transforming the lives of millions worldwide.
Why Participate?
- Participants will be compensated for participating in this study.
- Participants will be contributing valuable information that may benefit those with atopic dermatitis in the future.
- Participants will be helping to advance medical research.
Your Rights
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Individuals aged 6 years or older who are diagnosed with atopic dermatitis (eczema)
- Minors must have parental consent to participate in this study
- Must have had AD for at least 1 year
- Must not have any of the skin conditions: bullous diseases, psoriasis, cutaneous T cell lymphoma, dermatitis herpetiformis, Hailey-Hailey disease, or Darier’s disease
- Must not have a history of or currently have any of the following: tuberculosis, histoplasmosis, listeriosis, aspergillosis, HIV, herpes keratitis, Sjogren’s Syndrome, keratoconjunctivitis sicca, non-malignant lymphoproliferative disorders, bleeding disorders, hypersensitivity to local anesthetics, condition requiring anticoagulants
- Must not have had any parasitic infections within the last 12 months
- Must not have had any infection requiring treatment with systemic antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals in the last 4 weeks
- Must not have a history of keloid formation
- Must not have a history of alcohol or substance abuse in the past 2 years
- Must not have a history of serious or life-threatening reactions to tape or adhesives
- Must not have a planned major surgical procedure
- Must not have received a live vaccine in the last 7 weeks
- Must not have taken any systemic immunosuppressive/immunomodulating therapies (oral, IV, IM) such as steroids, cyclosporine, Janus kinase (JAK), mycophenolate, azathioprine, or methotrexate within the last 4 weeks
- Must not have received phototherapy in the last 4 weeks
- Must not have undergone treatment with a bleach bath in the past week
- Must not have used a chlorinated hot tub or pool in the past week
- Must not be currently participating in another clinical trial
- Must be able to attend 10 study visits at the research site over approximately 8 months
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants may need to stop certain medications or therapies during the study and apply Vanicream moisturizer twice daily to a specific skin area, avoiding certain ingredients in other moisturizers.
- Participants will be required to undergo a screening visit to determine eligibility, which includes signing a consent form, completing questionnaires, and reviewing medications/therapies. If eligible, they are assigned to one of three groups based on their atopic dermatitis (AD) condition and treatment history. The baseline assessment visit involves further questionnaires, physical exams, and initial sample collections.
- Participants will follow a structured visit schedule, and these involve physical exams, questionnaires, medication reviews, and various sample collections (blood, skin swabs, tape strips, biopsies). The study concludes with an End of Study Assessment or an Early Termination Visit if necessary
About the Research Center
National Jewish Health
Since 1899, we’ve made groundbreaking discoveries; educated providers, scientists, and patients; and integrated the latest discoveries with personalized, coordinated care for respiratory, cardiac, immune, and related disorders.
Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.