Clinical trial NCT04800185: Characterizing Skin Microbiome Change in Atopic Dermatitis
Official title: Characterizing Skin Microbiome Change in Atopic Dermatitis Patients After Targeted Topical Treatment Using Crisaborole Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema
Keywords: skin microbiome
crisaborole
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2021-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will function as their own internal control with one lesion left untreated
Primary purpose: HEALTH_SERVICES_RESEARCH

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 lead to a high burden of disease and associated patient morbidity with higher infection rates, emotional stress and associated psychological disease. The microbiome community contributes to human health through several mechanisms. Current research suggests that derangements in the normal microbiota may lead to inflammatory bowel disease, allergy, and metabolic syndromes. Specific to dermatology, new literature has demonstrated that changes in the microbiome may play a role in the development of atopic dermatitis.

With this study, the investigators hope to characterize the baseline atopic dermatitis skin microbiome and monitor the evolution of the participants skin microbiome during and after treatment with anti-inflammatory topical medications, specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa).


Eligibility criteria: Inclusion Criteria:

1. Patients aged 2 years or older at the time of consent.
2. Patients may be male or female.
3. Patients may have any skin phototype.
4. 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.
5. Atopic dermatitis affecting at least 5% of the patient's body surface area with at least two distinct lesional sites.
6. Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's Static Global Assessment (iSGA).
7. 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 Criteria:

1. Patients less than 2 years old at the time of consent.
2. Patients unable to provide written informed consent.
3. Patients must not have used systemic biologic therapy, systemic immunosuppressive therapy, or systemic immunomodulating therapy within three months of baseline visit.
4. Patients must not have had phototherapy within three months of baseline visit.
5. Patients must not have used topical corticosteroids or topical calcineurin inhibitor within 28 days of baseline visit.
6. Patients must not have previously been treated with topical phosphodiesterase-4 inhibitor.
7. Patients must not have a known hypersensitivity reaction to crisaborole or any of its known vehicle components.
8. Patients must not have any active skin infection at the time of screening.
9. Patients must not have any other overlying inflammatory disease such as psoriasis.
10. Patients must not be currently pregnant, breastfeeding or planning pregnancy during the study.

Primary outcomes:
measure: To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine - Dermatology Clinical Research
state: California
Study officials:
affiliation: University of California, Irvine
name: Natasha Atanaskova Mesinkovska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: