NCT04800185

Characterizing Skin Microbiome Change in Atopic Dermatitis

Characterizing Skin Microbiome Change in Atopic Dermatitis Patients After Targeted Topical Treatment Using Crisaborole Ointment

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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).

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	Crisaborole 2% Top Oint	To analyze the skin microbiome of patients with atopic dermatitis before, during, and after treatment with crisaborole 2% ointment
GENETIC	Skin Microbiome Swabs	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.

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2021-03-16
• Last updated: 2024-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study