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Characterizing Skin Microbiome Change in Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04800185
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : May 19, 2021
Information provided by (Responsible Party):
Katerina Yale, MD, University of California, Irvine

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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Dermatitis Eczema Drug: Crisaborole 2% Top Oint Genetic: Skin Microbiome Swabs Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Treatment group 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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04800185

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Contact: Cristina Nguyen, MD, MS, MHA (949) 824-7103
Contact: Katerina Yale, MD (949) 824-7103

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United States, California
University of California, Irvine - Dermatology Clinical Research Recruiting
Irvine, California, United States, 92697
Contact: Cristina H Nguyen, MD    949-824-7103   
Contact: Katerina L Yale, MD    (949) 824-7103   
Principal Investigator: Natasha Mesinkovska, MD, PhD         
Sub-Investigator: Katerina L Yale, MD         
Sub-Investigator: Cristina H Nguyen, MD, MS         
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Natasha Atanaskova Mesinkovska, MD, PhD University of California, Irvine
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Responsible Party: Katerina Yale, MD, Prinicipal Investigator, University of California, Irvine Identifier: NCT04800185    
Other Study ID Numbers: 2019-5479
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Katerina Yale, MD, University of California, Irvine:
skin microbiome
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases