Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04800185
Other study ID # 20195479
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2