Characterizing Skin Microbiome Change in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT04800185|
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : May 19, 2021
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).
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Atopic Dermatitis Eczema||Drug: Crisaborole 2% Top Oint Genetic: Skin Microbiome Swabs||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will function as their own internal control with one lesion left untreated|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Characterizing Skin Microbiome Change in Atopic Dermatitis Patients After Targeted Topical Treatment Using Crisaborole Ointment|
|Actual Study Start Date :||March 23, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||April 2022|
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.
- To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis. [ Time Frame: 16 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800185
|Contact: Cristina Nguyen, MD, MS, MHA||(949) email@example.com|
|Contact: Katerina Yale, MD||(949) firstname.lastname@example.org|
|United States, California|
|University of California, Irvine - Dermatology Clinical Research||Recruiting|
|Irvine, California, United States, 92697|
|Contact: Cristina H Nguyen, MD 949-824-7103 email@example.com|
|Contact: Katerina L Yale, MD (949) 824-7103 firstname.lastname@example.org|
|Principal Investigator: Natasha Mesinkovska, MD, PhD|
|Sub-Investigator: Katerina L Yale, MD|
|Sub-Investigator: Cristina H Nguyen, MD, MS|
|Principal Investigator:||Natasha Atanaskova Mesinkovska, MD, PhD||University of California, Irvine|