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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% Top Oint | Drug | To analyze the skin microbiome of patients with atopic dermatitis before, during, and after treatment with crisaborole 2% ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis. | To analyze the atopic dermatitis microbiome using advanced genomic techniques after treatment with topical PDE4 inhibitors. Using 16S library preparation, sequencing, merging of MiSeq paired-end sequence reads, and identification of operational taxonomic units, the investigators hope to identify the bacterial and fungal content of skin microbiome samples from 20 AD participants before and after treatment with crisaborole at a total of 6 visits over 16 weeks. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Atanaskova Mesinkovska, MD, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine - Dermatology Clinical Research | Irvine | California | 92697 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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Subjects will function as their own internal control with one lesion left untreated
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| Skin Microbiome Swabs | Genetic | At the baseline visit the investigator will identify sites for swabbing the skin including one affected distinct crisaborole-treated AD lesion, and one untreated AD lesion. The lesions will both be sampled at baseline, 14 days into treatment, 28 days into treatment, 3 months into treatment, and 4 weeks after treatment completion. Photographs of each lesion will be taken for reference. Skin swabs will be obtained in a sterile fashion using a BD Culture SwabsTM EZ Collection and Transport System (or equivalent) and soaked with sterilized 0.15 M NaCl and 0.1% Tween-20. The samples will be frozen at -80 C, kept at this temperature, and stored until analysis may be completed. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |