Characterizing Skin Microbiome Change in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800185
• Other study ID #: 20195479
• Status: Completed
• Phase: Early Phase 1
• Start date: March 23, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Irvine - Dermatology Clinical Research	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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