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Characterizing Skin Microbiome Change in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis Eczema

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Crisaborole 2% Top Oint

Skin Microbiome Swabs

About this trial

This is an interventional health services research trial for Atopic Dermatitis focused on measuring skin microbiome, crisaborole

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

University of California, Irvine - Dermatology Clinical Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04800185

First Posted

March 5, 2021

Last Updated

February 28, 2022

Sponsor

University of California, Irvine

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04800185

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 23, 2021 (Actual)

Primary Completion Date

April 30, 2022 (Anticipated)

Study Completion Date

April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis, Atopic Dermatitis Eczema

Keywords

skin microbiome, crisaborole

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Subjects will function as their own internal control with one lesion left untreated

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Crisaborole 2% Top Oint

Intervention Description

To analyze the skin microbiome of patients with atopic dermatitis before, during, and after treatment with crisaborole 2% ointment

Intervention Type

Genetic

Intervention Name(s)

Skin Microbiome Swabs

Intervention Description

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 Measure Information:

Title

To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis.

Description

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 2 years or older at the time of consent. Patients may be male or female. Patients may have any skin phototype. 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. Atopic dermatitis affecting at least 5% of the patient's body surface area with at least two distinct lesional sites. Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's Static Global Assessment (iSGA). 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: Patients less than 2 years old at the time of consent. Patients unable to provide written informed consent. Patients must not have used systemic biologic therapy, systemic immunosuppressive therapy, or systemic immunomodulating therapy within three months of baseline visit. Patients must not have had phototherapy within three months of baseline visit. Patients must not have used topical corticosteroids or topical calcineurin inhibitor within 28 days of baseline visit. Patients must not have previously been treated with topical phosphodiesterase-4 inhibitor. Patients must not have a known hypersensitivity reaction to crisaborole or any of its known vehicle components. Patients must not have any active skin infection at the time of screening. Patients must not have any other overlying inflammatory disease such as psoriasis. Patients must not be currently pregnant, breastfeeding or planning pregnancy during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natasha Atanaskova Mesinkovska, MD, PhD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Irvine - Dermatology Clinical Research

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Characterizing Skin Microbiome Change in Atopic Dermatitis

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