Characterizing Skin Microbiome Change in Atopic Dermatitis

NCT04800185 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 20195479
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Keywords

skin microbiome; crisaborole

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment group

OTHER

Drug: Crisaborole 2% Top Oint; Genetic: Skin Microbiome Swabs

Interventions

Crisaborole 2% Top Oint DRUG

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

Treatment group

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.

Treatment group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Pfizer: collaborator

Study Sites (1)

University of California, Irvine - Dermatology Clinical Research

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Natasha Atanaskova Mesinkovska, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

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

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 16, 2021
• Study Start: March 23, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)