Status:
COMPLETED
Characterizing Skin Microbiome Change in Atopic Dermatitis
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Pfizer
Conditions:
Atopic Dermatitis
Atopic Dermatitis Eczema
Eligibility:
All Genders
2+ years
Phase:
EARLY_PHASE1
Brief Summary
Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions ...
Eligibility Criteria
Inclusion
- Patients aged 2 years or older at the time of consent.
- Patients may be male or female.
- Patients may have any skin phototype.
- Patients with a clinical diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria. Atopic dermatitis diagnosis must be stable at least for 1 month per caregiver or patient.
- Atopic dermatitis affecting at least 5% of the patient's body surface area with at least two distinct lesional sites.
- Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's Static Global Assessment (iSGA).
- If greater than or equal to 18 years old at the time of consent, is able to provide written informed consent and will comply with all study procedures. If less than 18 years old at the time of consent, parent or guardian is able to provide written informed consent with all children greater than or equal to 7 years old at the time of consent also providing written assent, and will comply with all study procedures.
Exclusion
- Patients less than 2 years old at the time of consent.
- Patients unable to provide written informed consent.
- Patients must not have used systemic biologic therapy, systemic immunosuppressive therapy, or systemic immunomodulating therapy within three months of baseline visit.
- Patients must not have had phototherapy within three months of baseline visit.
- Patients must not have used topical corticosteroids or topical calcineurin inhibitor within 28 days of baseline visit.
- Patients must not have previously been treated with topical phosphodiesterase-4 inhibitor.
- Patients must not have a known hypersensitivity reaction to crisaborole or any of its known vehicle components.
- Patients must not have any active skin infection at the time of screening.
- Patients must not have any other overlying inflammatory disease such as psoriasis.
- Patients must not be currently pregnant, breastfeeding or planning pregnancy during the study.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04800185
Start Date
March 23 2021
End Date
April 30 2022
Last Update
February 2 2024
Active Locations (1)
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1
University of California, Irvine - Dermatology Clinical Research
Irvine, California, United States, 92697